Catalog Hemostasis IL 2018-2019 EN

2018-19 Hemostasis
Product Line Catalog

Innovation is here.
We’re pleased to present our newest product catalog for Hemostasis
testing. You’ll find proof of our passion and our commitment to you and
your patients on every page.
Only IL o ers industry-leading ACL TOP analyzers, HemosIL assays,

HemoHub Intelligent Data Manager, ProDx Remote Support Suite and
HemoCell Specialized Lab Automation. If your goals include improving
quality, e ciency and patient care while reducing costs, there’s an IL
Hemostasis testing solution for you. It’s all right here.
For more information, contact your local Werfen sales representative

or distributor, or visit instrumentationlaboratory.com.
Abbreviations
aβ2GPI .................................Anti-β2 Glycoprotein-I LIS .........................................Laboratory Information System
aCL .......................................Anti-Cardiolipin LMWH .................................Low Molecular Weight Heparin
ACL H/T ..........................ACL Hundred/Thousand Series lyo .........................................Lyophilized
TM
APC ......................................Activated Protein C NIBSC ..................................National Institute for Biological Standards and Controls (UK)
APC-R V ............................Activated Protein C Resistance caused by Factor V Leiden Mutation PC .........................................Protein C
aPL .......................................Antiphospholipid PE ..........................................Pulmonary Embolism
APS ......................................Antiphospholipid Syndrome PF4 .......................................Platelet Factor 4
APTT....................................Activated Partial Thromboplastin Time PF4-H ..................................Platelet Factor 4-Heparin
AT .........................................Antithrombin PI ...........................................Plasmin Inhibitor
C4BP ...................................C4b-Binding Protein PIVKA ..................................Protein Induced by Vitamin K Antagonists/Absence
CLSI......................................Clinical and Laboratory Standards Institute PLG.......................................Plasminogen
DDU .....................................D-Dimer Units PS ..........................................Protein S
DIC ........................................Disseminated Intravascular Coagulation PT ..........................................Prothrombin Time
dRVVT ................................Diluted Russell’s Viper Venom Test PTP .......................................Pretest Probability
DVT ......................................Deep Vein Thrombosis Q.F.A....................................Quantitative Fibrinogen Assay
FII, FV, FVII, FVIII, FIX, FX, FXI, RCo ......................................Ristocetin Cofactor
FXII, FXIII ............................Factors II, V, VII—XIII SCT .......................................Silica Clotting Time
FDP ......................................Fibrin/Fibrinogen Degradation Products SK..........................................Streptokinase
FEU ......................................Fibrinogen Equivalent Units TT ..........................................Thrombin Time
FIB ........................................Fibrinogen UFH ......................................Unfractionated Heparin
HIT ........................................Heparin-Induced Thrombocytopenia VKA ......................................Vitamin K Antagonist
IgA ........................................Immunoglobulin A VTE.......................................Venous Thromboembolism
IgG ........................................Immunoglobulin G VWD ....................................von Willebrand Disease
IgM........................................Immunoglobulin M VWF:Act ...........................von Willebrand Factor Activity
INR........................................International Normalized Ratio VWF:Ag ............................von Willebrand Factor Antigen
ISI ..........................................International Sensitivity Index VWF:RCo ..........................von Willebrand Factor Ristocetin Cofactor Activity
ISTH .....................................International Society on Thrombosis and Hemostasis VWF:CB .............................von Willebrand Factor Collagen Binding
LA .........................................Lupus Anticoagulant WHO....................................World Health Organization
liq...........................................Liquid
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Index
HemosIL® Assays D-Dimer HS 500 Controls . . . . . . . . . . . . . 13 Thrombophilia Abnormal Control 2* . . . . . . . . . . . . . . . . . 30
D-Dimer HS . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Liquid Antithrombin . . . . . . . . . . . . . . . . . . . 23 Abnormal Control 3* . . . . . . . . . . . . . . . . . 30
General Screening and D-Dimer 500* . . . . . . . . . . . . . . . . . . . . . . . . . 13 Antithrombin . . . . . . . . . . . . . . . . . . . . . . . . . . 23
D-Dimer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Anticoagulant Testing
D-Dimer Controls (Liquid) . . . . . . . . . . . . . 14
Protein C . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 HemosIL Solutions
PT ProClot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
D-Dimer Controls. . . . . . . . . . . . . . . . . . . . . . 14 ProClot Diluent . . . . . . . . . . . . . . . . . . . . . . . . 23 Sample Diluent . . . . . . . . . . . . . . . . . . . . . . . . 33
ReadiPlasTin® . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 D-Dimer HS 2000* . . . . . . . . . . . . . . . . . . . . 14 Factor Diluent . . . . . . . . . . . . . . . . . . . . . . . . . 33
RecombiPlasTin® 2G . . . . . . . . . . . . . . . . . . . . 7 Free Protein S
D-Dimer HS 2000 Controls* . . . . . . . . . . . 14 (antigenic immunoassay) . . . . . . . . . . . 24 Reference Emulsion . . . . . . . . . . . . . . . . . . . 33
PT-Fibrinogen HS Plus . . . . . . . . . . . . . . . . . 7 AcuStar D-Dimer . . . . . . . . . . . . . . . . . . . . . . 14 Wash-R Emulsion . . . . . . . . . . . . . . . . . . . . . 33
PT-Fibrinogen . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Protein S Activity . . . . . . . . . . . . . . . . . . . . . . 24
AcuStar D-Dimer Controls. . . . . . . . . . . . . 14 Factor V Leiden . . . . . . . . . . . . . . . . . . . . . . . 24 Cleaning Solution (Clean A) . . . . . . . . . . . 33
INR Validate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Cleaning Agent (Clean B) . . . . . . . . . . . . . 33
ISI Calibrate . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Fibrinolysis Homocysteine . . . . . . . . . . . . . . . . . . . . . . . . . 24
Homocysteine Controls . . . . . . . . . . . . . . . 24 Rinse Solution
ISIweb Software . . . . . . . . . . . . . . . . . . . . . . . . 8 FDP* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 (for ACL TOP® Family) . . . . . . . . . . . . . . 33
Xpert® HemosIL FII & FV . . . . . . . . . . . . . . . 25
FDP Calibrator* . . . . . . . . . . . . . . . . . . . . . . . 15 AcuStar Triggers . . . . . . . . . . . . . . . . . . . . . . 33
APTT FDP Controls* . . . . . . . . . . . . . . . . . . . . . . . . . 15
FII & FV DNA Control . . . . . . . . . . . . . . . . . 25
SynthASil® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 GeneXpert® System . . . . . . . . . . . . . . . . . . . 25 AcuStar System Rinse . . . . . . . . . . . . . . . . . 33
Plasminogen . . . . . . . . . . . . . . . . . . . . . . . . . . 15 AcuStar Cleaning Solution. . . . . . . . . . . . . 33
SynthAFax® . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Plasmin Inhibitor (α2-Antiplasmin) . . . . . 15
APTT-SP . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 Antiphospholipid Syndrome (APS)
Calcium Chloride 0.025 M . . . . . . . . . . . . . . 9 Bleeding Disorders Silica Clotting Time . . . . . . . . . . . . . . . . . . . . 27
dRVVT Screen . . . . . . . . . . . . . . . . . . . . . . . . . 27 Instruments
Fibrinogen Clauss Coagulation Factors dRVVT Confirm . . . . . . . . . . . . . . . . . . . . . . . . 27
Factor II, V, VII and ACL® Systems . . . . . . . . . . . . . . . . . . . . . . . . . 35
Fibrinogen-C and Fibrinogen-C XL . . . . . . 9 LA Positive Control . . . . . . . . . . . . . . . . . . . . 27 ACL TOP Family 50 Series . . . . . . . . . . . . 36
Q.F.A. Thrombin and Q.F.A. XL . . . . . . . . . 9 X Deficient Plasmas . . . . . . . . . . . . . . . . . 17 LA Negative Control . . . . . . . . . . . . . . . . . . 27
Factor VIII, IX, XI and ACL TOP 750/CTS/LAS . . . . . . . . . . . . . . . 37
AcuStar Anti-Cardiolipin . . . . . . . . . . . . . . 27 ACL TOP 550 CTS . . . . . . . . . . . . . . . . . . . . 38
UFH/LMWH XII Deficient Plasmas . . . . . . . . . . . . . . . . 17 AcuStar Anti-Cardiolipin Controls . . . . . 28
Liquid Anti-Xa . . . . . . . . . . . . . . . . . . . . . . . . . 10 FVII Deficient Plasma. . . . . . . . . . . . . . . . . . 17 ACL TOP 350 CTS . . . . . . . . . . . . . . . . . . . . . 39
AcuStar Anti-β2 Glycoprotein-I . . . . . . . . 28 ACL AcuStar® . . . . . . . . . . . . . . . . . . . . . . . . 40
Heparin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Factor XIII Antigen . . . . . . . . . . . . . . . . . . . . . 17 AcuStar Anti-β2 Glycoprotein-I Controls ... 28
UF Heparin Controls. . . . . . . . . . . . . . . . . . . 10 ELECTRACHROME Factor VIII . . . . . . . . . 17 ACL Elite®/Elite Pro. . . . . . . . . . . . . . . . . . . . 41
AcuStar Anti-β2 GPI Domain 1. . . . . . . . . . . 28
LMW Heparin Controls . . . . . . . . . . . . . . . . 10 AcuStar Anti-β2 GPI Domain 1 Controls. . . . 28
Heparin Calibrators . . . . . . . . . . . . . . . . . . . . 10
von Willebrand Disease
von Willebrand Factor Antigen . . . . . . . . 19 AcuStar Multi-Ab Controls . . . . . . . . . . . . 28 Lab Automation
DOACs von Willebrand Factor Activity . . . . . . . . 19
Liquid Anti-Xa* . . . . . . . . . . . . . . . . . . . . . . . . 10 von Willebrand Factor Ristocetin HemosIL Plasma Calibrators and IT Solutions
Rivaroxaban Calibrators* . . . . . . . . . . . . . . . 11 Cofactor Activity* . . . . . . . . . . . . . . . . . . . 19 HemoHub . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Rivaroxaban Controls* . . . . . . . . . . . . . . . . . . 11 AcuStar von Willebrand and Controls ProDx . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Apixaban Calibrators* . . . . . . . . . . . . . . . . . . 11 Factor Antigen* . . . . . . . . . . . . . . . . . . . . . 20 Calibration Plasma . . . . . . . . . . . . . . . . . . . . 29 HemoCell . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Apixaban Controls*. . . . . . . . . . . . . . . . . . . . . 11 AcuStar von Willebrand Factor Normal Control Assayed . . . . . . . . . . . . . . 29
Ristocetin Cofactor Activity* . . . . . . . . 20
Direct Thrombin Inhibitor Assay* . . . . . . . 11
Dabigatran Calibrators* . . . . . . . . . . . . . . . . 11 AcuStar von Willebrand Factor
Low Abnormal Control Assayed . . . . . . . 29
High Abnormal Control Assayed . . . . . . 29
Consumables
Dabigatran Controls* . . . . . . . . . . . . . . . . . . . 11 Collagen Binding Activity* . . . . . . . . . . 20 Special Test Control Level 1 . . . . . . . . . . . . 29 and Accessories
AcuStar von Willebrand Special Test Control Level 2 . . . . . . . . . . . 29
Other Factor Controls* . . . . . . . . . . . . . . . . . . . . 20 Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Low Fibrinogen Control . . . . . . . . . . . . . . 30 Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Thrombin Time . . . . . . . . . . . . . . . . . . . . . . . . 12 Routine Control Level 1* . . . . . . . . . . . . . . 30
Hepatocomplex* . . . . . . . . . . . . . . . . . . . . . . 12 Heparin-Induced Routine Control Level 2*. . . . . . . . . . . . . . 30
Pro-IL-Complex* . . . . . . . . . . . . . . . . . . . . . . 12 Thrombocytopenia (HIT) Routine Control Level 3* . . . . . . . . . . . . . 30 Instrument Specs/Tests
PCX/HPX Thromboplastin Diluent* . . . . 12 HIT-Ab(PF4-H) . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 QC Plasma Coagulation
Instrument Specs/Tests . . . . . . . . . . . . . . . 55
HIT-Ab(PF4-H) Controls . . . . . . . . . . . . . . . . . . 21 Control Level I* . . . . . . . . . . . . . . . . . . . . 30
Fibrin Formation and Degradation AcuStar HIT-IgG(PF4-H) . . . . . . . . . . . . . . . . . 22 QC Plasma Coagulation
D-Dimer AcuStar HIT Controls . . . . . . . . . . . . . . . . . 22 Control Level II* . . . . . . . . . . . . . . . . . . . . 30
D-Dimer HS 500 . . . . . . . . . . . . . . . . . . . . . . 13 AcuStar Multi-Ab Controls . . . . . . . . . . . . 22 Normal Control 1* . . . . . . . . . . . . . . . . . . . . 30
D-Dimer HS 500 Controls (Liquid)* . . . 13
Visit instrumentationlaboratory.com for the latest product list and
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*Not 510(k)-cleared and not Canadian licensed. See page for specific country saleability information. Not saleable in the US. Not available in all countries.
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General Screening and Anticoagulant
General Screening and Anticoagulant Monitoring/Measurement for Testing

Monitoring/Measurement for Testing
Prothrombin Time (PT)
Product Description Key Features Kit Configuration
ReadiPlasTin For the quantitative determination in human • Liquid, ready-to-use PT reagent 5 x 0.5 mL ReadiPlasTin Reagent (liq)
(p/n 0020301300 - 10 mL) citrated plasma of PT and Fibrinogen on • Human tissue factor, recombinant technology 5 x 9.5 mL ReadiPlasTin Diluent (liq)
ACL TOP Family and ACL TOP Family 50
Series systems to evaluate the extrinsic • ISI range ~1.00 on ACL systems
(p/n 0020301400 - 20 mL) 5 x 1 mL ReadiPlasTin Reagent (liq)
coagulation pathway and the monitoring • Insensitive ≤ 1.0 U/mL of Heparin
of VKA therapy. 5 x 19 mL ReadiPlasTin Diluent (liq)
• 10-day onboard stability
• Standardized using WHO-recommended
protocol
RecombiPlasTin 2G For the quantitative determination in human • Human tissue factor, recombinant technology 5 x 8 mL RecombiPlasTin 2G (lyo)
(p/n 0020002950 - 8 mL) citrated plasma of PT and Fibrinogen on • ISI range ~1.00 on ACL systems 5 x 8 mL RecombiPlasTin 2G Diluent (liq)
IL Hemostasis systems to evaluate the
extrinsic coagulation pathway and the • Insensitive ≤ 1.0 U/mL of Heparin
(p/n 0020003050 - 20 mL) 5 x 20 mL RecombiPlasTin 2G (lyo)
monitoring of VKA therapy. • Up to 10-day onboard stability
5 x 20 mL RecombiPlasTin 2G Diluent (liq)
• Elevated reconstituted stability
• Standardized using WHO-recommended
protocol
PT-Fibrinogen HS Plus For simultaneous determination of • Rabbit brain thromboplastin extract 5 x 8.5 mL Rabbit Thromboplastin (lyo)
(p/n 0008469810) PT and Fibrinogen, to evaluate the • ISI range ~1.2 5 x 8.5 mL Bu er (liq)
extrinsic coagulation pathway and
monitor VKA therapy in human citrated • Insensitive ≤ 0.5 U/mL of Heparin
plasma on IL Hemostasis systems. • Standardized using WHO-recommended
protocol
PT-Fibrinogen For simultaneous determination of PT • Rabbit brain thromboplastin extract 10 x 8 mL Rabbit Thromboplastin (lyo)
(p/n 0009756710) and Fibrinogen, to evaluate the extrinsic • ISI range ~2.0
coagulation pathway and monitor
VKA therapy in human plasma on IL • Insensitive ≤ 1 U/mL of Heparin
Hemostasis systems.
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PT
INR Validate A tri-level quality control for monitoring • Determines if local ISI assignment is needed Level 1: 1 x 1 mL (lyo) of human VKA plasma
(p/n 0020010500) the accuracy of INR reporting with • Validates newly established local ISI with an INR range of 1.6–2.4
designated HemosIL PT reagents on IL Level 2: 1 x 1 mL (lyo) of human VKA plasma
Hemostasis systems, in conjunction with • Reagent-specific INR levels
with an INR range of 2.5–3.5
ISIweb software. • Levels 1–3 comprised of donors on
long-term anticoagulant therapy Level 3: 1 x 1 mL (lyo) of human VKA plasma
with an INR range of 3.8–5.0
• Levels of FII, FVII, FIX, FX, PC, PS and
PIVKA are equivalent to concentrations
expected in VKA-treated patients
• Follows ISTH and CLSI guidelines for
validation of INR and ISI plasmas
ISI Calibrate A set of four certified plasmas to establish • Reagent-specific INR levels Level A: 1 x 1 mL (lyo) of human plasma
(p/n 0020010600) instrument-/reagent-specific local ISI and • Level A comprised of normal human donors with an INR range of 0.9–1.1
Mean Normal PT with designated HemosIL Level B: 1 x 1 mL (lyo) of human VKA
PT reagents on IL Hemostasis systems in • Levels B–D comprised of donors
on VKA therapy. Levels of FII, FVII, plasma with an INR range of 1.6–2.4
conjunction with ISIweb software.
FIX, FX, PC, PS and PIVKA are equivalent Level C: 1 x 1 mL (lyo) of human VKA
to concentrations expected in plasma with an INR range of 2.5–3.5
VKA-treated patients Level D: 1 x 1 mL (lyo) of human VKA plasma
• Follows ISTH and CLSI guidelines for with an INR range of 3.8–5.0
validation of INR and ISI plasmas
ISIweb Software A web-based ISIweb software tool • Accessible through mywerfen.com

for calculating PT seconds and INR results • Easy and intuitive interface
using HemosIL INR Validate, HemosIL ISI
Calibrate and designated HemosIL PT • Increases e ciency in benchmarking
reagents on IL Hemostasis systems. standardized values
• Maximizes performance of IL
Hemostasis systems
• ISTH- and CLSI-compliant
• Electronically archives and reports
all activities on local ISI assignment
and validation
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APTT
SynthASil For the determination of APTT in human • Synthetic phospholipid technology 5 x 10 mL APTT Reagent (liq)
citrated plasma on IL Hemostasis systems, to • Liquid, ready-to-use 5 x 10 mL Calcium Chloride (liq)
(p/n 0020006800)
evaluate the intrinsic coagulation pathway,
and to monitor Heparin therapy. • Micronized silica activator
• Sensitive to the contact phase activation
• 30-day open vial stability
SynthAFax For the determination of APTT • Synthetic phospholipid technology 5 x 10 mL APTT Reagent (liq)
(p/n 0020007400) in human citrated plasma on IL Hemostasis • Liquid, ready-to-use 5 x 10 mL Calcium Chloride (liq)
systems, to evaluate the intrinsic coagulation
pathway, and to monitor Heparin therapy. • Ellagic acid activator
• Sensitive to Factors VIII and IX
APTT-SP For the determination of APTT • Synthetic phospholipid technology 5 x 9 mL APTT Reagent (liq)
in citrated plasma on IL Hemostasis systems, Liquid, ready-to-use 5 x 8 mL Calcium Chloride (liq)
(Synthetic as a general screening procedure to evaluate
•
Phospholipids) the intrinsic coagulation pathway and • Micronized silica activator
(p/n 0020006300) monitor patients on Heparin. • Sensitive to the contact phase activation
Calcium Chloride 0.025 M Used in combination with APTT-SP 10 x 8 mL Calcium Chloride (liq)
(p/n 0019741910) on IL Hemostasis systems.
Fibrinogen Clauss
Fibrinogen-C For the quantitative determination of • Purified Thrombin 10 x 2 mL Bovine Thrombin (lyo)
(p/n 0020301100) Fibrinogen in human citrated plasma, • Insensitive to Heparin < 1.0 U/mL
based on the Clauss method, on IL 10 x 5 mL Bovine Thrombin (lyo)
Hemostasis systems. • Good linear range
(p/n 0020003900 - XL)
Q.F.A. Thrombin For the quantitative determination of • Purified Thrombin 10 x 2 mL Bovine Thrombin (lyo)
(p/n 0020301800 - 2 mL) Fibrinogen in human citrated plasma, • Bovine origin
based on the Clauss method, on IL 10 x 5 mL Bovine Thrombin (lyo)
Hemostasis systems. • Good stability
(p/n 0020301700 - 5 mL) • 100 UNIH/mL Thrombin
• Insensitive to Heparin < 2.0 U/mL
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UF/LMW Heparin
Liquid Anti-Xa For the quantitative determination • One-stage assay 5 x 2.5 mL Factor Xa Reagent (liq)
(p/n 0020302600) of UFH and LMWH activity in human • Uses endogenous Antithrombin from 5 x 3 mL Chromogenic Substrate (liq)
citrated plasma on IL Hemostasis systems. patient sample
• One universal calibration curve for UFH
and LMWH
• Linear range of 0–2 IU/mL for UFH and LMWH
• Liquid, ready-to-use format
Heparin For the quantitative determination • Linear response 0–1 U/mL for Heparin 1 x 5 mL Factor Xa Reagent (lyo)
(p/n 0030009400) of UFH and LMWH activity in human • Enhanced reagent stability 1 x 4 mL Chromogenic Substrate
citrated plasma on IL Hemostasis systems. (S-2765) (lyo)
1 x 3 mL Antithrombin (lyo)
1 x 8 mL Bu er
UF Heparin Controls For quality control of HemosIL Liquid • Assayed Controls 5 x 1 mL Low UF Heparin (lyo)
(p/n 0020300300) heparin assay when testing for UFH on • Comprised of human plasma containing 5 x 1 mL High UF Heparin Control (lyo)
IL Hemostasis systems. UFH only
• Bi-level Low and High Controls
LMW Heparin Controls For quality control of HemosIL Liquid • Assayed Controls 5 x 1 mL Low LMW Heparin (lyo)
(p/n 0020300200) heparin assay when testing for LMWH • Comprised of human plasma containing 5 x 1 mL High LMW Heparin Control (lyo)
on IL Hemostasis systems. LMWH only
• Bi-level Low and High Controls
Heparin Calibrators For calibration of the HemosIL Liquid • One set of calibrators for both UFH 3 x 1 mL Calibrator 1-3 (lyo)
(p/n 0020300600) Heparin assay on IL Hemostasis systems. and LMWH
• Calibrator set with predetermined
Heparin concentrations
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DOACs
Direct Thrombin For the quantitative determination of the • Dilute thrombin-based method 3 x 2 mL DTI Thrombin Reagent (lyo)
Inhibitor Assay* Direct Thrombin Inhibitor Dabigatran in • Excellent linear range (20–2000 ng/mL) 3 x 2.2 mL DTI Thrombin Diluent (liq)
citrated human plasma on the ACL TOP
(p/n 0020302800) • Low limit of detection (2 ng/mL) 3 x 2 mL DTI Plasma Diluent (lyo)
Family of analyzers. Intended to be used
for the measurement of active Dabigatran • Una ected by Heparin up to 2.2 IU/mL
levels in situations where measurement
is warranted.
Dabigatran Calibrators* For the calibration of the HemosIL • Bi-level calibrators 5 x 2 mL Dabigatran Calibrator 1 (lyo)
(p/n 0020013400) Direct Thrombin Inhibitor assay on the • Dabigatran Calibrator 1 (0 ng/mL) 5 x 1 mL Dabigatran Calibrator 2 (lyo)
ACL TOP Family of analyzers.
• Dabigatran Calibrator 2 (~500 ng/mL)
Dabigatran Controls* For the quality control of the HemosIL • Bi-level controls 5 x 1 mL Dabigatran Low Control (lyo)
(p/n 0020013500) Direct Thrombin Inhibitor assay on the • Dabigatran Low Control (~50 ng/mL) 5 x 1 mL Dabigatran High Control
ACL TOP Family of analyzers.
• Dabigatran High Control (~200 ng/mL)
Liquid Anti-Xa* For the quantitative determination of • One-stage assay 5 x 2.5 mL Factor Xa Reagent (liq)
(p/n 0020302601) unfractionated heparin (UFH) and low • Uses endogenous Antithrombin from 5 x 3 mL Chromogenic Substrate (liq)
molecular weight heparin (LMWH) activity patient sample
in human citrated plasma on IL Coagulation
System when used in conjunction with • One universal calibration curve for UFH
HemosIL Heparin Calibrators. Also intended and LMWH
for the measurement of direct FXa • Linear range of 0.04–2 IU/mL for UFH
inhibitor concentrations (e.g., Rivaroxaban, and LMWH
Apixaban) in human citrated plasma • Linear range of 20–1000 ng/mL for
on ACL TOP Family Systems when used Rivaroxaban
with HemosIL Rivaroxaban and/or
• Linear range of 15–1000 ng/mL for Apixaban
Apixaban calibrators.
• Liquid, ready-to-use format
Rivaroxaban Calibrators* For the calibration of the HemosIL Liquid • Bi-level calibrators 5 x 1 mL Rivaroxaban Calibrator 1 (lyo)
(p/n 0020013600) Anti-Xa assay when testing for Rivaroxaban • Rivaroxaban Calibrator 1 (0 ng/mL) 5 x 1 mL Rivaroxaban Calibrator 2 (lyo)
on ACL TOP Systems.
• Rivaroxaban Calibrator 2 (~500 ng/mL)
Rivaroxaban Controls* For the quality control of the HemosIL • Bi-level controls 5 x 1 mL Rivaroxaban Low Control (lyo)
(p/n 0020013700) Liquid Anti-Xa assay when testing for • Rivaroxaban Low Control (~80 ng/mL) 5 x 1 mL Rivaroxaban High Control (lyo)
Rivaroxaban on ACL TOP Systems.
• Rivaroxaban High Control (~300 ng/mL)
Apixaban Calibrators* For the calibration of the HemosIL Liquid • Bi-level calibrators 5 x 1 mL Apixaban Calibrator 1 (lyo)
(p/n 0020014200) Anti-Xa assay when testing for Apixaban • Apixaban Calibrator 1 (0 ng/mL) 5 x 1 mL Apixaban Calibrator 2 (lyo)
on ACL TOP Systems.
• Apixaban Calibrator 2 (~500 ng/mL)
Apixaban Controls* For the quality control of the HemosIL • Bi-level controls 5 x 1 mL Apixaban Low Control (lyo)
(p/n 0020014300) Liquid Anti-Xa assay when testing for • Apixaban Low Control (~80 ng/mL) 5 x 1 mL Apixaban High Control (lyo)
Apixaban on ACL TOP Systems.
• Apixaban High Control (~300 ng/mL)
*Not 510(k)-cleared. Not saleable in the US. Not available in all countries.
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Other
Thrombin Time For the quantitative determination of • Purified Thrombin 4 x 2, 5 or 8 mL Bovine Thrombin (lyo)
(p/n 0009758515) Thrombin Time in human citrated plasma • Di erent reconstitutions for desired 1 x 9 mL Bu er (liq)
on IL Hemostasis systems. normal range:
5 mL: ~11–18 seconds
• Specific reconstitution for Heparin therapy
Hepatocomplex* For the detection of clinical situations • Specific for VKA monitoring 5 x 7 mL Rabbit Calcium
(p/n 0009758710) associated with congenital or acquired • PIVKA-insensitive Thromboplastin (lyo)
deficiencies of Factors II-VII-X in human 5 x 3 mL Bovine Plasma (lyo)
citrated plasma on IL Hemostasis systems. • Insensitive to Heparin < 0.5 U/mL
Used for the control of VKA therapy, both • ISI ~1.3
stabilized and in combination with Heparin.
Due to its endogenous coagulation inhibitor
insensitivity, this assay, combined with
HemosIL Pro-IL-Complex, can identify
the presence of inhibitors.
Pro-IL-Complex* For the control of VKA therapy, both • Specific for VKA monitoring 5 x 7 mL Bovine Thromboplastin (lyo)
(p/n 0009758810) stabilized and in combination with • PIVKA-sensitive 5 x 3 mL Bovine Plasma (lyo)
Heparin, in human citrated plasma on IL
Hemostasis systems. Due to its sensitivity • Insensitive to Heparin < 0.5 U/mL
to endogenous coagulation inhibitors, • ISI ~1.2
this assay, combined with HemosIL
Hepatocomplex, can identify the presence
of inhibitors (e.g., PIVKA).
PCX/HPX Thromboplastin For the reconstitution of Thromboplastin • Dedicated saline solution for PCX/HPX 1 x 100 mL
Diluent* reagents, Pro-IL-Complex and
Hepatocomplex assays (calibration
(p/n 0008469600)
and analysis).
*Not 510(k)-cleared and not Canadian licensed. Not for sale in the US and Canada.
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Fibrin Formation and Degradation
Fibrin Formation and Degradation/D-Dimer/Fibrinolysis

D-Dimer
D-Dimer HS 500 For the quantitative determination of • Automated, latex-enhanced immunoassay 3 x 4 mL Latex Reagent (liq)
(p/n 0020500100) D-Dimer in human citrated plasma on • Liquid, ready-to-use 3 x 6 mL Reaction Bu er (liq)
ACL TOP systems. For use in conjunction
with a clinical PTP assessment model to • Validated cut-o of 500 ng/mL 2 x 1 mL D-Dimer Calibrator (lyo)
exclude VTE in outpatients suspected of FEU on ACL TOP Family
DVT and PE. • Results in < 5 mins
D-Dimer HS 500 For the quality control of D-Dimer HS 500 • Liquid, ready-to-use 5 x 1 mL Level 1 D-Dimer HS 500 Control (liq)
assay performed on ACL TOP systems. Eliminates variability from reconstitution
Controls (Liquid) •
5 x 1 mL Level 2 D-Dimer HS 500 Control (liq)
(p/n 0022550030)* • Level 1 control recovers at cut-o value
• Reduces start-up time required for quality
(p/n 0020013100)** control
D-Dimer HS 500 For the quality control of D-Dimer HS 500 • Low Control: borderline level 5 x 1 mL High Control (lyo)
Controls assay performed on ACL TOP systems. • High Control: pathological level 5 x 1 mL Low Control (lyo)
(p/n 0020500200) • For use with D-Dimer HS 500
(p/n 0020500100)
D-Dimer HS For the quantitative determination of • Automated, latex-enhanced immunoassay 3 x 2 mL Latex Reagent (lyo)
(p/n 0020007700) D-Dimer in human citrated plasma on ACL • Validated cut-o of 230 ng/mL DDU on 3 x 8 mL Reaction Bu er (liq)
TOP systems. For use in conjunction with ACL TOP systems
a clinical PTP assessment model to exclude 2 x 1 mL D-Dimer Calibrator (lyo)
VTE in outpatients suspected of DVT and PE. • Results in < 5 mins
D-Dimer 500** For the quantitative determination of • Automated, latex-enhanced immunoassay 4 x 3 mL Latex Reagent (lyo)
(p/n 0020301000) D-Dimer in human citrated plasma on IL • Validated cut-o of 500 ng/mL FEU on 4 x 9 mL Reaction Bu er (liq)
Hemostasis systems. For use in conjunction IL Hemostasis systems
with a clinical PTP assessment model to 2 x 1 mL D-Dimer Calibrator (lyo)
exclude VTE in outpatients suspected of • Results in < 7 mins
DVT and PE.
D-Dimer For the quantitative determination of • Automated, latex-enhanced immunoassay 4 x 3 mL Latex Reagent (lyo)
(p/n 0020008500) D-Dimer in human citrated plasma on IL • Validated cut-o of 230 ng/mL DDU on 4 x 9 mL Reaction Bu er (liq)
Hemostasis systems. For use in conjunction IL Hemostasis systems
with a clinical PTP assessment model to 2 x 1 mL D-Dimer Calibrator (lyo)
exclude VTE in outpatients suspected of • Results in < 7 mins
DVT and PE.
*For US and Canada.

**Not 510(k)-cleared and not Canadian licensed. Not for sale in the US and Canada.
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D-Dimer
D-Dimer Controls For the quality control of D-Dimer, • Liquid, ready-to-use 5 x 1 mL Level 1 D-Dimer Control (liq)
(Liquid)* D-Dimer 500 and D-Dimer HS assays • Eliminates variability from reconstitution 5 x 1 mL Level 2 D-Dimer Control (liq)
on IL Hemostasis systems.
(p/n 0020013000) • Minimizes human error
• Reduces start-up time required for quality
control
D-Dimer Controls For the quality control of D-Dimer, • Low and High combined, o ers a 5 x 1 mL High Control (lyo)
(p/n 0020008610) D-Dimer 500 and D-Dimer HS assays complete quality control program 5 x 1 mL Low Control (lyo)
on IL Hemostasis systems. • For use with D-Dimer, D-Dimer HS and
D-Dimer 500
• Low D-Dimer Control: borderline level
• High D-Dimer Control: abnormal level
D-Dimer HS 2000** For the quantitative determination of • Automated, latex-enhanced immunoassay 3 x 4 mL Latex Reagent (liq)
(p/n 0020014400) D-Dimer in human citrated plasma on • Liquid, ready-to-use 3 x 6 mL Reaction Bu er (liq)
ACL TOP Family Systems.
• Extended linearity 0.5–32 g/mL, up to 2 x 1 mL D-Dimer Calibrator (lyo)
300 g/mL with automatic rerun
• Results in < 5 mins
D-Dimer HS 2000 For the quality control of D-Dimer HS 2000 • Low and High Controls combined o er 5 x 1 mL High Control (lyo)
Controls** assay on ACL TOP Family Systems. a complete quality control program 5 x 1 mL Low Control (lyo)
(p/n 0020014500) • For use with D-Dimer HS 2000
• Low Control: low D-Dimer levels
• High Control: high D-Dimer levels
AcuStar D-Dimer Fully automated chemiluminescent • Clinically validated 500 ng/mL FEU 1 D-Dimer Cartridge for 100 Tests (liq)
(p/n 0009802000) immunoassay for the quantitative cut-o value 1 x 1 mL D-Dimer Calibrator 1 (lyo)
determination of D-Dimer in human citrated • Extended 8-week onboard stability
plasma on the ACL AcuStar system as an 1 x 1 mL D-Dimer Calibrator 2 (lyo)
aid in the diagnosis of VTE (DVT and PE). • Extended linearity 54.3–74,000 ng/mL, up 1 D-Dimer Calibrator 1 Barcoded Tube
to 1,110,000 ng/mL with automatic rerun
1 D-Dimer Calibrator 2 Barcoded Tube
AcuStar D-Dimer For the quality control of D-Dimer assays • Low Control: borderline level 3 x 1 mL Low D-Dimer Control (lyo)
Controls performed on the ACL AcuStar system. • High Control: pathological level 3 x 1 mL High D-Dimer Control (lyo)
(p/n 0009802100) • Very High Control: high pathological level 3 x 1 mL Very High D-Dimer Control (lyo)
3 D-Dimer Low Control Barcoded Tubes
3 D-Dimer High Control Barcoded Tubes
3 D-Dimer Very High Control Barcoded Tubes
**Not currently 510(k)-cleared. For exclusive use in Japan.
Chemiluminescent technology assay. For use on ACL AcuStar Hemostasis Testing System.
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Fibrinolysis
FDP* For the quantitative determination of • Automated, latex-enhanced immunoassay 3 x 4 mL FDP Latex Reagent (liq)
(p/n 0020009900) Fibrinogen degradation products (FDP) • Innovative technology mitigates 3 x 4 mL FDP Reaction Bu er
in human citrated plasma on ACL TOP Fibrinogen interference
Family systems.
• Excellent agreement with commercially
available FDP test methods
• Enhanced analytical performance
with extended measurement range
of 2.5–120 g/mL
FDP Calibrator* For the calibration of FDP on • 5-vial calibrator set with predetermined 1x 1 mL FDP Calibrator 1 (lyo)
(p/n 0020009910) ACL TOP Family systems. FDP concentrations 1x 1 mL FDP Calibrator 2 (lyo)
1x 1 mL FDP Calibrator 3 (lyo)
1x 1 mL FDP Calibrator 0 Barcode Label
FDP Controls* For the quality control of FDP on • Low FDP Control targets low abnormal 3 x 1 mL Low FDP Control (lyo)
(p/n 0020009920) ACL TOP Family systems. FDP levels 3 x 1 mL High FDP Control (lyo)
• High FDP Control targets abnormal
FDP levels
Plasminogen For the quantitative determination of • Improved reagent stability 2 x 2.5 mL Streptokinase Reagent (lyo)
(p/n 0020009000) Plasminogen in human citrated plasma • Improved linearity 2 x 2 mL Chromogenic Substrate
on IL Hemostasis systems. S-2403 (lyo)
• Optimized specificity
Plasmin Inhibitor For the quantitative determination of • Detects quantitative plasmin-inhibitor- 2 x 2.5 mL Plasmin Reagent (lyo)
(α2-Antiplasmin) Plasmin Inhibitor in human citrated plasma deficiency 1 x 4 mL Chromogenic Substrate
(p/n 0020009200) on IL Hemostasis systems. • Minimized cross-reactivity with S-2403 (lyo)
α2-macroglobulin 2 x 9 mL Bu er (liq)
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COAGULATION FACTORS
Bleeding Disorders
Bleeding Disorders/Coagulation Factors

Coagulation Factors
Factor Deficient Plasma For use in combination with PT reagents to • Immunodepleted deficient plasmas 10 x 1 mL Factor Deficient Plasma (lyo)
FII (p/n 0020012200) determine specific Factor activity in citrated • Residual activity of specific Factor < 1%
plasma on IL Hemostasis systems.
FV (p/n 0020011500)
FVII (p/n 0020011700)
FX (p/n 0020010000)
Factor Deficient Plasma For use in combination with APTT reagents • Immunodepleted deficient plasmas 10 x 1 mL Factor Deficient Plasma (lyo)
FVIII (p/n 0020011800) to determine specific Factor activity in • Residual activity of specific Factor < 1%
citrated plasma on IL Hemostasis systems.
FIX (p/n 0020011900)
FXI (p/n 0020011300)
FXII (p/n 0020011200)
FVIII Deficient Plasma For use in combination with APTT reagents • Artificially depleted deficient plasma with 10 x 1 mL Factor Deficient Plasma (lyo)
(p/n 0020012800) to determine specific Factor activity in normal levels of von Willebrand Factor
citrated plasma on IL Hemostasis systems. (VWF) activity
• < 1% Residual FVIII activity
ELECTRACHROME For the quantitative determination • Chromogenic FVIII assay 1 x 6 or 7 mL Chromogenic Substrate (lyo)
Factor VIII of FVIII on ACL Elite/Elite Pro. 2 x 3 or 3.5 mL Factor Reagent (lyo)
(p/n 49730503) 2 x 24 mL Bu er (liq)
Factor XIII Antigen* For the quantitative determination of • Fully automated immunoturbidimetric assay 2 x 2.5 mL Latex Reagent (liq)
(p/n 0020201300) FXIII Antigen in human citrated plasma • Liquid, ready-to-use reagent 2 x 5 mL Bu er (liq)
• Correlates with activity assay** 2 x 6 mL Diluent (liq)
*FXIII antigen assays are exempt from 510(k)-clearance.

**IL, data on file.
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DISEASE
Willebrand Disease

vonWILLEBRAND
von Willebrand For the quantitative determination of VWF • Latex, particle-based immunoassay 2 x 3 mL Latex Reagent (liq)
Factor Antigen Antigen in human citrated plasma on IL • Liquid, ready-to-use 2 x 4 mL Reaction Bu er (liq)
Hemostasis systems.
(p/n 0020002300) • Results in < 7 minutes
von Willebrand For the quantitative determination of VWF • Automated, latex-enhanced immunoassay 2 x 4.5 mL Latex Reagent (lyo)
Factor Activity Activity in human citrated plasma on IL • Easy-to-use, labor-saving 2 x 4.5 mL Bu er (liq)
Hemostasis systems.
(p/n 0020004700) • Results in 12 minutes
• Good precision and correlation with
VWF:RCo Activity assays
VON
von Willebrand For the quantitative determination of • Automated, latex-enhanced 2 x 2 mL Latex Reagent (liq)
Factor Ristocetin VWF:RCo Activity in human citrated plasma immunoassay 2 x 1.6 mL Ristocetin (liq)
Cofactor Activity* on ACL TOP systems. • Liquid, ready-to-use 2 x 4 mL Reaction Bu er (liq)
(p/n 0020300900) • Recombinant technology replaces platelets 2 x 3.6 mL Diluent (liq)
• Excellent agreement with platelet
aggregation assays
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AcuStar von Willebrand For the quantitative determination of von • Fully automated chemiluminescent 1 VWF:Ag cartridge for 25 tests (liq)
Factor Antigen* Willebrand Factor Antigen in human citrated immunoassay 1 x 1 mL VWF:Ag Calibrator 1 (liq)
(p/n 0009802020) plasma on ACL AcuStar systems. • Extended linearity range to quantify 1 x 1 mL VWF:Ag Calibrator 2 (lyo)
VWF levels below 1%
1 VWF:Ag Calibrator 2 Barcoded Tube
• Broad working range enhances accuracy
at all medical decision levels for
VWD investigation
• 8-week onboard stability
AcuStar von Willebrand For the quantitative determination of von • Fully automated chemiluminescent, 1 VWF:RCo cartridge for 25 tests (liq)
Factor Ristocetin Willebrand Factor Ristocetin Cofactor platelet-free immunoassay 1 x 1 mL VWF:RCo Calibrator 1 (liq)
Cofactor Activity* Activity in human citrated plasma on ACL • Recombinant technology replaces
AcuStar systems. 1 x 1 mL VWF:RCo Calibrator 2 (lyo)
(p/n 0009802024) platelets and enhances accuracy
1 VWF:RCo Calibrator 2 Barcoded Tube
AcuStar von Willebrand For the quantitative determination of • Chemiluminescent immunoassay 1 VWF:CB Cartridge for 25 tests (liq)
Factor Collagen Binding von Willebrand Factor Collagen Binding • First and only fully automated VWF:CB assay 1 x 1 mL VWF:CB Calibrator 1 (liq)
Activity* Activity in human citrated plasma on
ACL AcuStar systems. • Cartridge-based, ready-to-use, for 1 x 1 mL VWF:CB Calibrator 2 (lyo)
(p/n 0009802044) unmatched simplicity 1 VWF:CB Calibrator 2 Barcoded Tube
• Enhanced sensitivity for High Molecular
Weight Multimer (HMWM) and intact VWF
collagen-binding site
AcuStar von Willebrand For the quality control of AcuStar VWF • For use with AcuStar VWF:Ag, AcuStar 3 x 1 mL Low VWF Control (lyo)
Factor Controls* assays performed on ACL AcuStar systems. VWF:RCo and AcuStar VWF:CB 3 x 1 mL Normal VWF Control (lyo)
(p/n 0009802119) • Results expressed in % 3 Low VWF Control Barcoded Tubes
• Low VWF Control reports in the 3 Normal VWF Control Barcoded Tubes
low-abnormal range
• Normal VWF Control reports in the
normal range
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Heparin-Induced Thrombocytopenia (HIT)
Heparin-Induced Thrombocytopenia (HIT)

HIT-Ab(PF4-H)* For the semi-quantitative detection of total • Automated, latex-enhanced immunoassay 2 x 1.8 mL Latex Reagent (liq)
(p/n 0020302700) immunoglobulin (lg) in human citrated • Liquid, ready-to-use 2 x 3.2 mL Stabilizer (liq)
plasma against PF4-H complexes on ACL
TOP systems. Heparin-associated antibodies • On-demand results in minutes 2 x 0.8 mL Complex (liq)
are commonly found in patients with HIT. • Validated 1.0 U/mL cut-o value 2 x 1 mL Calibrator (lyo)
HIT-Ab(PF4-H) Controls* For the quality control of HIT-Ab(PF4-H) assay • Low Control: borderline HIT antibody level 3 x 1 mL High Control (liq)
(p/n 0020013300) (p/n 0020302700). • High Control: abnormal HIT antibody level 3 x 1 mL Low Control (liq)
HIT-Ab(PF4-H) For the qualitative detection of • Automated, latex-enhanced immunoassay 2 x 1.8 mL Latex Reagent (liq)
(p/n 0020014600) anti-platelet-factor-4/heparin (PF4-H) • Liquid, ready-to-use 2 x 3.2 mL Stabilizer (liq)
antibodies. Anti-PF4/Heparin antibodies
are commonly found in patients with HIT. • On-demand results in minutes 2 x 0.8 mL Complex (liq)
• Validated 1.0 U/mL cut-o value 2 x 1 mL Calibrator (lyo)
HIT-Ab(PF4-H) Controls For the quality control of HIT-Ab(PF4-H) assay • Low Control: borderline HIT antibody level 3 x 1 mL High Control (liq)
(p/n 0020014700) (p/n 0020014600). • High Control: abnormal HIT antibody level 3 x 1 mL Low Control (liq)
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HIT
AcuStar HIT-IgG(PF4-H)* For the detection of IgG antibodies in • Fully automated, chemiluminescent 1 HIT-IgG(PF4-H) Cartridge for 25 Tests (liq)
(p/n 0009802028) human citrated plasma and serum that react immunoassay 1 x 1 mL HIT-IgG(PF4-H) Calibrator 1 (liq)
with PF4-H complexes on ACL AcuStar • Cartridge-based, ready-to-use,
systems. Heparin-associated antibodies are 1 x 1 mL HIT-IgG(PF4-H) Calibrator 2 (liq)
precalibrated assays
commonly found in patients with HIT.
• Results in ~30 minutes
• Extended 12-week onboard stability
• Results available ondemand, 24/7
• Validated 1.00 U/mL cut-o
• Uses serum or citrated plasma
AcuStar HIT Controls* For use with AcuStar HIT-IgG(PF4-H) • Results expressed in U/mL 3 x 1 mL Low HIT Control (liq)
(p/n 0009802122) (p/n 0009802028) and AcuStar HIT-Ab(PF4-H) • Low HIT Control: below cut-o value 3 x 1 mL High HIT Control (liq)
(p/n 0009802032) performed on • High HIT Control: above cut-o value
ACL AcuStar systems.
AcuStar Multi-Ab* For the quality control of the HemosIL • Liquid, ready-to-use multi-assay control 3 x 2 mL Low Multi-Ab Control (liq)
Controls AcuStar Anti-Cardiolipin IgG/IgM, Anti-ß2 material for monitoring chemiluminescent 3 x 2 mL High Multi-Ab Control (liq)
Glycoprotein-I IgG/IgM, HIT-Ab(PF4-H) aPL and HIT assays
(p/n 00009800003)
(p/n 0009802032) and HIT-IgG(PF4-H) • Low Control assesses precision and accuracy
(p/n 0009802028) as performed on at normal or cut-o antibody levels
ACL AcuStar systems. • High Control assesses precision and
accuracy at abnormal antibody levels
AcuStar HIT-IgG(PF4-H)** For the qualitative detection of IgG • Fully automated chemiluminescent 1 HIT-IgG(PF4-H) Cartridge for 25 Tests (liq)
(p/n 0009800127) antibodies in human serum or plasma that immunoassay 1 x 1 mL HIT-IgG(PF4-H) Calibrator 1 (liq)
react with Platelet Factor 4 (PF4) when • Cartridge-based, ready-to-use,
complexed to heparin on ACL AcuStar 1 x 1 mL HIT-IgG(PF4-H) Calibrator 2 (liq)
precalibrated assays
systems. Anti-PF4-H antibodies are
commonly found in patients with HIT. • Results in ~30 minutes
• Results available ondemand, 24/7
• Validated 1.00 U/mL cut-o
AcuStar HIT Controls** For the quality control of AcuStar HIT • Results expressed in U/mL 3 x 1 mL Low HIT Control (liq)
(p/n 0009800131) assays performed on ACL AcuStar Systems. • Low HIT Control: below cut-o value 3 x 1 mL High HIT Control (liq)
For use with AcuStar HIT-IgG(PF4-H)
(p/n 0009800127). • High HIT Control: above cut-o value
**For US and Canada.
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Thrombophilia
Thrombophilia
Liquid Antithrombin For the quantitative determination • Liquid, ready-to-use ACL Elite/Elite Pro
(p/n 0020002500) of AT in human citrated plasma on • Factor Xa-based assay 4 x 4 mL FXa Reagent (liq)
IL Hemostasis systems.
• Insensitive to Heparin Cofactor II 2 x 2 mL Chromogenic Substrate
• Enhanced reagent stability S-2765 (liq)
(p/n 0020030100) • Improved onboard stability ACL TOP Family, ACL TOP Family 50 Series
4 x 4.5 mL FXa Reagent (liq)
4 x 4.5 mL Chromogenic Substrate S-2765 (liq)
(p/n 0020300400) ACL TOP Family, ACL TOP Family 50 Series
ACL 200–7000
2 x 2 mL FXa Reagent (liq)
2 x 2 mL Chromogenic Substrate
S-2765 (liq)
Antithrombin For the quantitative determination • Fully automated 2 x 2.5 mL Factor Xa Reagent (lyo)
(p/n 0020008900) of AT in human citrated plasma on • Factor Xa-based assay 2 x 2 mL Chromogenic Substrate
IL Hemostasis systems. S-2765 (lyo)
• Enhanced reagent stability
Protein C For the quantitative determination • Improved reagent stability and linearity 2 x 2.5 mL Protein C Activator (lyo)
(p/n 0020300500) of PC in human citrated plasma on 2 x 2.5 mL Chromogenic Substrate S-2366 (lyo)
IL Hemostasis systems.
1 x 8 mL Diluent (liq)
ProClot For the quantitative determination • Functional clotting assay 4 x 1.5 mL Protein C Activator (lyo)
(p/n 0008468310) of PC in human citrated plasma on • Can be used in combination with 4 x 1 mL Protein C Deficient Plasma (lyo)
IL Hemostasis systems. HemosIL APTT-SP 2 x 1 mL Protein C Control Plasma (lyo)
ProClot Diluent For the calibration and analysis 1 x 100 mL

(p/n 0008468600) of ProClot.
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Thrombophilia
Free Protein S For the quantitative determination • Immunoturbidimetric assay 3 x 4 mL C4BP Bu er (liq)
(p/n 0020002700) of free PS in human citrated plasma • Binds to natural free PS ligand (C4BP) 3 x 4 mL C4BP Latex (lyo)
• High specificity (no interference with 3 x 2 mL Anti PS mAb Latex (lyo)
FV Leiden mutation)
• Excellent correlation with ELISA and
latex-based assays
Protein S Activity For the quantitative determination • Fully automated, functional assay 3 x 2 mL Protein S Reagent (lyo)
(p/n 0020302000) of free PS in human citrated plasma • 6-hour onboard stability at 15°C on 2 x 6 mL Calcium Reagent (liq)
on IL Hemostasis systems. ACL TOP systems 3 x 2 mL Protein S Deficient Plasma (lyo)
Factor V Leiden For determination of resistance to activated • High-specificity FV Leiden detection 2 x 4 mL APTT Reagent (liq)
(p/n 0020008700) PC, caused by the FV mutation, in plasma • 100% sensitivity for FV:Q506 mutation 2 x 4 mL Factor-V Reagent Plasma (lyo)
from untreated individuals and from
patients on Heparin or VKA therapy. • Factor V Reagent Plasma (p/n 2 x 2 mL APC/CaCl2 (lyo)
0020008800) included in kit or 2 x 2 mL CaCl2 (liq)
sold separately
2 x 1 mL APC Control Plasma Level 1 (lyo)
2 x 1 mL APC Control Plasma Level 2 (lyo)
Homocysteine For the quantitative determination • The first fully automated, 2 x 2 mL a-SAH Latex Reagent (lyo)
(p/n 0020007800) of total L-homocysteine in human citrated immunoturbidimetric Homocysteine 2 x 2 mL Reductant (liq)
plasma on IL Hemostasis systems. assay for the Hemostasis laboratory
2 x 2 mL Enzyme (liq)
• Linearity < 4.5–60 μmol/L
2 x 2.5 mL Conjugate (liq)
2 x 9 mL Bu er (liq)
2 x 1 mL Calibrator (liq)
Homocysteine Controls For the quality control of total • Level 1: borderline homocysteine levels 3 x 1 mL Homocysteine Control Level 1 (lyo)
(p/n 0020007900) L-homocysteine assays. • Level 2: abnormal homocysteine levels 3 x 1 mL Homocysteine Control Level 2 (lyo)
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Thrombophilia
Xpert HemosIL FII For the rapid detection of FII and FV • Qualitative diagnostic genotyping test 10 FII & FV Assay Cartridges
& FV Combined Test single-point mutations, from sodium citrate • One cartridge = one sample
(p/n 460GXHEMOSIL-10) or EDTA anticoagulated whole blood, on
the GeneXpert system. • Uses citrated or EDTA whole blood;
fully integrated sample prep
• FII & FV testing in a single cartridge
• Results in 30 minutes
• Self-controlled
FII & FV DNA Control For heterozygous quality control to monitor • Heterozygous control for both 3 x 0.5 mL FII & FV (liq)
(p/n 0020003500) analytical performance of the extraction, FII (G20210A) and FV Leiden
amplification and detection steps of the (G1691A) mutations
Xpert HemosIL FII & FV assay on the
GeneXpert Dx system. Used in the detection
of the FII and FV mutations.
GeneXpert System For automation and integration of sample • Self-contained, fully integrated, real-time,
purification, nucleic acid amplification and automated PCR system
detection of the target sequence in simple • Single cartridge for DNA extraction
or complex samples, using real-time PCR. to results
• < 4 random-access, independent modules
per system
Molecular technology.
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Antiphospholipid Syndrome (APS)
Antiphospholipid Syndrome (APS)

Silica Clotting Time For the detection of Lupus Anticoagulant • Screen (low phospholipid concentration) 3 x 5 mL SCT Screen (liq)
(p/n 0020004800) (LA) in human citrated plasma on IL and Confirm (high phospholipid 3 x 5 mL SCT Confirm (liq)
Hemostasis systems. concentration) in one kit
3 x 10 mL SCT CaCl2 (liq)
• Liquid formulation, easy-to-use,
fully automated
• Suitable for mixing studies and patients
receiving VKA therapy
dRVVT Screen For the detection of LA in human citrated • Easy-to-use, fully automated 10 x 2 mL dRVVT Screen (lyo)
(p/n 0020301500) plasma on IL Hemostasis systems. • No Heparin interference < 1.0 U/mL 10 x 2 mL dRVVT Confirm (lyo)
• Improved stability: 15 days at 2–8°C and
dRVVT Confirm 3 days at 15°C onboard ACL TOP systems
(p/n 0020301600)
LA Positive Control For use as an LA Positive Quality Control • Developed from Platelet-poor plasma 10 x 1 mL LA Positive Control (lyo)
(p/n 0020012500) of LA assays on IL Hemostasis systems. from LA-positive patients
• Stability: 24 hours at 2–8°C and 24 hours
at 15°C onboard ACL TOP systems
LA Negative Control For use as an LA Negative Quality Control • Optimized for LA mixing tests 10 x 1 mL LA Negative Control (lyo)
(p/n 0020012600) of LA assays on IL Hemostasis systems. • Negative Control developed from
human citrated platelet-poor plasma
from > 100-donor pool
• Stability: 24 hours at 2–8°C and 24 hours
at 15°C onboard ACL TOP systems
AcuStar For the semi-quantitative measurement of • Fully automated, chemiluminescent 1 aCL IgG Cartridge for 50 Tests (liq)
Anti-Cardiolipin (aCL) aCL IgG or IgM antibodies in human citrated immunoassay 1 x 1 mL aCL IgG Calibrator 1 (liq)
plasma, or serum, on ACL AcuStar systems, • Cartridge-based, ready-to-use,
IgG (p/n 0009802004) 1 x 1 mL aCL IgG Calibrator 2 (liq)
as an aid in the diagnosis of thrombotic precalibrated assays
IgM (p/n 0009802008) disorders related to primary and secondary 1 aCL IgM Cartridge for 50 Tests (liq)
APS when used in conjunction with other • Extended 6-week onboard stability
laboratory and clinical findings. • Extremely wide linearity ranges, with 1 x 1 mL aCL IgM Calibrator 1 (liq)
and without rerun 1 x 1 mL aCL IgM Calibrator 2 (liq)
• Clinically validated 20 U/mL cut-o for
all assays
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APS
AcuStar For the quality control of AcuStar aCL • Assigned for AcuStar aCL IgG or IgM 3 x 1 mL Low aCL IgG Control (liq)
Anti-Cardiolipin Controls IgG or IgM assays performed on ACL • Results expressed in U/mL 3 x 1 mL High aCL IgG Control (liq)
AcuStar systems.
IgG (p/n 0009802104) • Low aCL Control: borderline level
3 x 1 mL Low aCL IgM Control (liq)
• High aCL Control: pathological level
IgM (p/n 0009802108) 3 x 1 mL High aCL IgM Control (liq)
AcuStar Anti-ß2 For the semi-quantitative measurement of • Fully automated, chemiluminescent 1 aß2GPI IgG Cartridge for 50 Tests (liq)
Glycoprotein-I aß2GPI IgG or IgM antibodies in human immunoassay 1 x 1 mL aß2GPI IgG Calibrator 1 (liq)
citrated plasma or serum on ACL AcuStar • Cartridge-based, ready-to-use,
IgG (p/n 0009802012) 1 x 1 mL aß2GPI IgG Calibrator 2 (liq)
systems, as an aid in the diagnosis of precalibrated assays
IgM (p/n 0009802016) thrombotic disorders related to APS when 1 aß2GPI IgM Cartridge for 50 Tests (liq)
used in conjunction with other laboratory
and clinical findings. • Extremely wide linearity ranges, with and 1 x 1 mL aß2GPI IgM Calibrator 1 (liq)
without rerun 1 x 1 mL aß2GPI IgM Calibrator 2 (liq)
• Clinically validated 20 U/mL cut-o for
all assays
AcuStar Anti-ß2 For the quality control of AcuStar aß2GPI • Assigned for AcuStar aß2GPI IgG or IgM 3 x 1 mL Low aß2GPI IgG Control (liq)
Glycoprotein-I Controls IgG or IgM assays performed on ACL • Results expressed in U/mL 3 x 1 mL High aß2GPI IgG Control (liq)
AcuStar systems.
IgG (p/n 0009802112) • Low aß2GPI Control: borderline level
3 x 1 mL Low aß2GPI IgM Control (liq)
• High aß2GPI Control: pathological level
IgM (p/n 0009802116) 3 x 1 mL High aß2GPI IgM Control (liq)
AcuStar Anti-ß2GPI For the semi-quantitative determination of • Fully automated, chemiluminescent 1 Anti-ß2GPI Domain 1 Cartridge for
Domain 1 IgG auto-antibodies to ß2GPI Domain 1 in immunoassay 50 tests (lyo)
(p/n 00009800015) human serum or citrated plasma on ACL • Cartridge-based precalibrated assay 1 Resuspension Bu er (liq)
AcuStar systems used in conjunction with
• Extended 60-day onboard stability 1 x 1 mL Anti-ß2GPI Domain 1 Calibrator 1 (liq)
clinical and other laboratory findings as an
aid in the diagnosis of APS. • Extremely wide linear ranges, with and 1 x 1 mL Anti-ß2GPI Domain 1
without rerun Calibrator 2 (lit)
• 99.6% specificity for APS
AcuStar Anti-ß2GPI For the quality control of AcuStar Anti- • Assigned for AcuStar Anti-ß 2GPI 3 x 1 mL Anti-ß2GPI Domain 1 Low
Domain 1 Controls ß2GPI Domain 1 assay performed on ACL Domain 1 Control (liq)
(p/n 00009800022) AcuStar systems. • Results expressed in U/mL 3 x 1 mL Anti-ß2GPI Domain 1 High
• Low Control assesses precision and Control (liq)
accuracy at normal or cut-o
antibody levels
• High Control assesses precision and
AcuStar Multi-Ab* For the quality control of the HemosIL • Liquid, ready-to-use multi-assay control 3 x 2 mL Low Multi-Ab Control (liq)
Controls AcuStar Anti-Cardiolipin IgG/IgM, Anti-ß2 material for monitoring chemiluminescent 3 x 2 mL High Multi-Ab Control (liq)
Glycoprotein-I IgG/IgM, and HIT-IgG(PF4-H) aPL and HIT assays
(p/n 00009800003)
assays as performed on the ACL AcuStar • Low Control: assesses precision and accuracy
system. at normal or cut-o antibody levels
• High Control: assesses precision and
*Not available in all countries.

Chemiluminescent technology assay. For use on ACL AcuStar Hemostasis Testing System. 28
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Plasma Calibrators and Controls

Calibration Plasma For the calibration of assays on • Single calibrator for IL Hemostasis 10 x 1 mL Calibration Plasma (lyo)
(p/n 0020003700) IL Hemostasis systems. systems, including several parameters
• 24-hour stability for several assays
• Traceability vs. NIBSC standards
Normal Control For the quality control of assays in the • Easy-to-use, reliable source of normal 10 x 1 mL Normal Control (lyo)
Assayed normal range on IL Hemostasis systems. human plasma
(p/n 0020003110) • 24-hour reconstituted stability for
routine assays
Low Abnormal For the quality control of assays in the low • Citrated pooled plasma from healthy 10 x 1 mL Low Abnormal Control (lyo)
Control Assayed abnormal range on IL Hemostasis systems. donors (not on Heparin or VKA)
(p/n 0020003210 ) • Modified to simulate an abnormal
coagulation sample
• 24-hour reconstituted stability for
routine assays
High Abnormal For the quality control of assays in the high • Single control for several assays 10 x 1 mL High Abnormal Control (lyo)
Control Assayed abnormal range on IL Hemostasis systems. • 24-hour reconstituted stability for
(p/n 0020003310) routine assays
• Modified to simulate an abnormal
coagulation sample
Special Test For quality control in the low abnormal • Traceability vs. NIBSC standards 10 x 1 mL Special Test Level 1 (lyo)
Control Level 1 range for the chromogenic tests: AT, PLG, PI,
PC and FVIII; quality control of free PS assay
(p/n 0020011000)
in the range of 50–60% activity; and quality
control of VWF assays (Antigen, Activity
and RCo) in the normal range on IL
Hemostasis systems.
Special Test For quality control in the high abnormal • Traceability vs. NIBSC standards 10 x 1 mL Special Test Level 2 (lyo)
Control Level 2 range for the chromogenic tests: AT, PLG, PI,
PC and FVIII; quality control of free PS and
(p/n 0020012000)
Factor (clotting) assays (II, V, VII, VIII, IX, XI,
XII) in the range of 20–40% activity; and
quality control of VWF assays (Antigen and
RCo) in the low abnormal range on IL
Hemostasis systems.
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Low Fibrinogen For a complete quality control • Abnormal control assigned using the 10 x 1 mL Low Fibrinogen Control (lyo)
Control program in the abnormal range on PT-based and Clauss methods
IL Hemostasis systems. • Traceability vs. NIBSC standards and
(p/n 0020004200)
WHO recommendations
Routine Control For quality control of Hemostasis assays • Normal range assay quality control 10 x 1 mL Routine Control Level 1 (lyo)
Level 1* in the normal range, to assess precision and • Assesses precision and accuracy of PT,
accuracy of PT, APTT and FIB tests on APTT and Fibrinogen tests
(p/n 0020005600)
Hemostasis systems.
Routine Control For quality control of Hemostasis assays • Low abnormal range assay quality control 10 x 1 mL Routine Control Level 2 (lyo)
Level 2* in the low abnormal range, to assess • Assesses precision and accuracy of PT
precision and accuracy of PT and APTT and APTT tests
(p/n 0020005700)
tests on Hemostasis systems.
Routine Control For quality control of Hemostasis assays • High abnormal range assay quality control 10 x 1 mL Routine Control Level 3 (lyo)
Level 3* in the high abnormal range, to assess the • Assesses precision and accuracy of PT
precision and accuracy of PT and APTT and APTT tests
(p/n 0020005800)
tests on Hemostasis systems.
QC Plasma Normal human plasma used as a normal • Normal control 10 x 1 mL QC Plasma Level I (lyo)
Coagulation control in routine Hemostasis assays such
Control Level I* as PT, APTT, FIB, AT and PC to detect
significant changes in certain variables
(p/n 0020010700) inherent in Hemostasis testing.
QC Plasma Abnormal human plasma used as a • Mid-range abnormal control 10 x 1 mL QC Plasma Level II (lyo)
Coagulation mid-range abnormal control in routine
Control Level II* Hemostasis assays such as the one-stage
PT, APTT, FIB, AT and PC, to detect
(p/n 0020010800) significant changes in certain variables
inherent in Hemostasis testing.
HemosIL Normal For the quality control of assays in the • Assigned for routine assays 10 x 1 mL Normal Control 1 (lyo)
Control 1* normal range IL Hemostasis systems. • 24-hour reconstituted stability
(p/n 0020013900)
HemosIL Abnormal For the quality control of assays in the low • Assigned for routine assays 10 x 1 mL Abnormal Control 2 (lyo)
Control 2* abnormal range on IL Hemostasis systems. • 24-hour reconstituted stability
(p/n 0020014000) • Modified to simulate an abnormal
coagulation sample
HemosIL Abnormal For the quality control of assays in the high • Assigned for routine assays 10 x 1 mL Abnormal Control 3 (lyo)
Control 3* abnormal range on IL Hemostasis systems. • 24-hour reconstituted stability
(p/n 0020014100) • Modified to simulate an abnormal
coagulation sample
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Controls
Low High
Normal Special Test Special Test
Abnormal Abnormal Normal Abnormal Abnormal
Reagent Control Control Control Control 1* Control 2* Control 3*
Control Control
Assayed Level 1 Level 2
Assayed Assayed
PT • • • • • •
APTT • • • • • •
Fibrinogen • • • •
Thrombin Time • • • •
Pro-IL-Complex* • • •
Hepatocomplex* • • •
Antithrombin • • • • • •
Protein C • • • •
Protein S • • • •
VWF Antigen • • •
VWF Activity • •
VWF:RCo** • • •
FII, V, VII, X • •
FVIII, IX, XI, XII • •
FXIII Antigen*** • •
Plasminogen • • •
Plasmin Inhibitor • • •
*Not 510(k)-cleared and not Canadian licensed. Not saleable in the US and Canada. Not available in all countries.
**Not 510(k)-cleared. Not saleable in the US. Not available in all countries.
***FXIII antigen assays are exempt from 510(k)-clearance. Not available in all countries.
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Calibration Plasma
ACL TOP Family/

Reagent ACL Elite/Elite Pro ACL 7000
ACL TOP Family 50 Series
PT • • •
APTT • • •
Fibrinogen • • •
TT (2 mL) • • •
TT (5 mL) • • •
TT (8 mL) • • •
Pro-IL-Complex* • • •
Hepatocomplex* • • •
Antithrombin • • •
ProClot • • •
Protein C • • •
Protein S Activity • • •
Free Protein S Antigen • •
VWF Antigen • •
VWF Activity • •
VWF:RCo* •
FII, V, VII, X • • •
FVIII, IX, XI, XII • • •
FXIII Antigen** •
Plasminogen • • •
Plasmin Inhibitor • • •
**FXIII assays are exempt from 510(k)-clearance.
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Solutions
Solutions
Product Description Kit Configuration
Sample Diluent For calibration of PT and FIB tests on ACL 7000 systems. 1 x 100 mL
(p/n 0009756800)
Factor Diluent For calibration of PT and FIB tests for Factor assays. Also to dilute calibrators, 1 x 100 mL
(p/n 0009757600) controls and patient samples in AT and PLG chromogenic kits.
Reference Emulsion Optical reference for nephelometric analysis and washing solution for 1 x 500 mL
(p/n 0009756900) ACL 7000 systems.
Wash-R Emulsion Optical reference for nephelometric analysis and washing solution on 1 x 1000 mL
(p/n 0020002400) ACL Elite/Elite Pro systems.
Cleaning Solution (Clean A) Cleaning solution for ACL systems. 1 x 500 mL

(p/n 0009831700)
Cleaning Agent (Clean B) Cleaning solution and decontaminant for ACL systems. 1 x 80 mL
(p/n 0009832700)
Rinse Solution Rinsing solution for ACL TOP systems. 1 x 4000 mL

(for ACL TOP Family)
(p/n 0020302400)
AcuStar Triggers Catalyst and oxidizer solutions for triggering chemiluminescent reaction on the 2 x 250 mL
(p/n 0009802201) ACL AcuStar systems.
AcuStar System Rinse For magnetic wash cycles and as a rinsing solution on the ACL AcuStar systems. 1 x 5000 mL
(p/n 0009802200)
AcuStar Cleaning Solution Cleaning solution for the ACL AcuStar systems. 6 x 4 mL
(p/n 0009802204)
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Instruments
Instruments
ACL Systems
Easy, comprehensive solutions
Instrumentation Laboratory was the first to automate clotting assays, and we are now the world’s leading
developer of Hemostasis systems. Our ACL testing systems use advanced optical technology and set a new
standard for precision and operational simplicity, while our HemosIL reagents are first in flexibility, reliability
and accuracy. Using the same system, routine clotting tests or specialty assays are performed with ease.
Working with the specific volume and demand in your lab, IL can build a complete testing solution that meets
your needs and helps deliver quality care.
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NEW
A breakthrough in Hemostasis testing

New ACL TOP Family 50 Series For high-volume labs
Offering the most advanced automation and quality management, from routine to specialty ACL TOP 750/CTS/LAS
assays. Standardized across all ACL TOP systems—for superior performance across your Run more tests in less time—user-friendly
and high throughput for routine analysis in
entire testing process.
laboratories with the heaviest workloads.
• Same quality results
• Same comprehensive reagent portfolio
For medium- to high-volume labs
• Same powerful and intuitive software ACL TOP 550 CTS
Highly automated testing processes in routine,
• Same features and usability
medium- to high-volume and specialty labs.
And now:
• Same pre-analytical sample checks with assay-specific thresholds For medium-volume labs
• Same advanced lab accreditation support ACL TOP 350 CTS
Smallest ACL TOP system for routine or
• Same advanced quality management
specialty assays in medium-volume labs.
Perfect companion to ACL TOP 750 CTS
or ACL TOP 550 CTS system.
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NEW
Advanced testing automation and quality management

for high-volume labs
Maximum speed, intelligence and simplicity
Delivers the highest level of performance for the best possible results—in any lab environment.
Every ACL TOP 750 system maximizes simplicity, speed and productivity, elevating testing automation
and quality to the highest level. Provides true standardization across all applications—whether used in
routine, high-volume, specialty labs or as part of a fully integrated Laboratory Automation System.
Various configurations offer

ACL TOP 750 LAS Connects to
greater flexibility LAS-compliant tracks
• ACL TOP 750 (Open-Tube Sampling) • Follows CLSI Guidelines (AUTO 1–5)
for electromechanical interfaces - Thermo Fisher
• ACL TOP 750 CTS (Closed-Tube Sampling) - Abbott
• ACL TOP 750 LAS (Laboratory Automation System) • Provides "Point in space sampling"
- Inpeco
• Open system compatible with most
- Beckman Coulter
laboratory automation track systems
- Siemens
• Eliminates need for costly and slow - IDS
robotic interface
- GLP
- HemoCell
Analyzer automation Continuous operation Fast turnaround

• Barcoded reagents • Continual loading and unloading • Up to 360 PT/hour
• Continuous onboard reagent of samples and reagents via racks, • PT from standby in < 3 minutes
stability monitoring with no system interruption
• Samples loaded on any rack, in any
• Automatic QC frequency execution • Uninterrupted cuvette loading position, at any time, including STAT
• Rerun and reflex testing capabilities • Uninterrupted waste disposal
• Fully automated reporting of factor assays Simple maintenance
with Parallelism
• Daily maintenance, ordered by user and
• Auto-verification and uploading of results performed by system, in < 5 minutes
• Closed-Tube Sampling via cap-piercing • “Maintenance overdue” notifications alert user
(CTS models only)
• Remote instrument diagnostics and
troubleshooting via web interface in real
time* (optional)
*The ACL TOP 50 Family Series is not available in all countries.
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NEW

for medium- to high-volume labs
Superior functionality at the right size—now with automated
assay-specific pre-analytical sample checks
Combines unique testing capabilities with end-to-end automation for simplicity
and maximum operator productivity. Its comprehensive menu for routine
and specialty assays is ideal for broad-spectrum lab needs and testing volumes.
New automated pre-analytical sample checks, advanced automated quality
management and accreditation support tools enhance efficiency and
patient care.

• Barcoded reagents • Continual loading and unloading of samples and • Up to 240 PT/hour
• Continuous onboard reagent stability monitoring reagents via racks, with no system interruption • PT from standby in ~3 minutes
• Automatic QC frequency execution • Uninterrupted cuvette loading • Samples loaded on any rack, in any
• Rerun and reflex testing capabilities • Uninterrupted waste disposal position, at any time, including STAT
• Fully automated reporting of factor assays Simple maintenance • High capacity: 800 cuvettes,
with Parallelism 80 samples, 40 reagents
• Closed-Tube Sampling via cap-piercing • “Maintenance overdue” notifications
to alert user
troubleshooting via web interface in
real time* (optional)
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NEW

for medium-volume labs
Small footprint, same user-friendly features—now with automated
assay-specific pre-analytical sample checks
Compact in size, yet robust in features, and fully automated for fast and accurate
results, with no specialized operator training required. Testing for routine
or specialty assays is simple. New automated pre-analytical sample checks,
advanced automated quality management and accreditation support
tools minimize the risk of errors and enhance e ciency. The ideal solution
for medium-volume labs and a perfect complement to the ACL TOP 750
or ACL TOP 550 CTS systems for a fully integrated testing environment.

• Barcoded reagents • Continual loading and unloading of samples and • Up to 110 PT/hour
• Continuous onboard reagent stability monitoring reagents via racks, with no system interruption • PT from standby in ~3 minutes
• Automatic QC frequency execution • Uninterrupted cuvette loading • Samples loaded on any rack, in any
• Rerun and reflex testing capabilities • Uninterrupted waste disposal position, at any time, including STAT
• Fully automated reporting of factor assays Simple maintenance • High capacity: 800 cuvettes,
with Parallelism 40 samples, 26 reagents
• Closed-Tube Sampling via cap-piercing • “Maintenance overdue” notifications to
alert user
troubleshooting via web interface in real
time* (optional)
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The first specialty-testing analyzer that offers full automation of Highly accurate
highly sensitive immunoassays for the Hemostasis lab. Specialty • Automated chemiluminescent technology enhances accuracy
testing can be completed in as little as 25 minutes, with no special and sensitivity
training required. Provides superior accuracy and sensitivity to • Immunoglobulin isotype di erentiation improves specificity
specialty and routine immunoassay testing.
• High sensitivity and broad working range with one- or two-stage
A true breakthrough in specialty testing. immunoassays
It’s about time. And accuracy. • Virtually no optical interference
Test panel
• D-Dimer Fast and efficient
• aCL IgG • Unprecedented e ciency for key specialty assays
• aCL IgM • Up to 20 di erent assays onboard and available
24 hours/day, 7 days/week
• aß2GPI IgG
• aß2GPI IgM • 60 tests/hour throughput
• HIT-IgG(PF4-H) • Results in ~30 minutes
• VWF:Ag* • STAT or batch sample processing
• VWF:RCo* • Up to 12-week onboard stability
Simple to use
• Self-contained, ready-to-use, precalibrated reagent cartridges
eliminate reagent handling
• Integrated barcode reader automatically tracks cartridges and samples
• Easy rack loading accommodates up to 30 samples onboard
Chemiluminescent technology.
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ACL Elite and ACL Elite Pro

Simple, comprehensive solutions for the
Hemostasis Laboratory
Enable routine, specialty and STAT testing on compact, convenient
and easy-to-use systems. Whether your volume needs are low or
high, a host of innovative and valuable performance features include:
• Random-access processing for minimized turnaround time
• STAT PT and APTT available in as little as 8 minutes
• Barcoded reader for reagents (standard on ACL Elite Pro system)
• Superior walk-away capacity for 40 samples and up to 260
cuvettes onboard
• STAT Interrupt and continuous sample loading for uninterrupted
testing capability
• Integrated color touchscreen
• Intuitive software streamlines system operation
• Proven and reliable mechanics for robust operation with
minimal maintenance
• Comprehensive test menu makes specialty testing as simple as
routine testing
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Lab Automation and IT Solutions
Solutions for Hemostasis testing

IL continues to innovate Hemostasis testing to advance patient care and enhance laboratory efficiency. HemoHub
Intelligent Data Manager centralizes the entire Hemostasis testing operation from a single workstation, while ProDx
Remote Support Suite provides automated remote monitoring and technical support to ensure continuous peak
efficiency. HemoCell Specialized Lab Automation is the world’s first workcell solution exclusively for Hemostasis testing.
It enhances productivity and quality, reducing cost and keeping Hemostasis expertise where it belongs—in your lab.
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NEW
Proactive vigilance for peak e ciency

Automated monitoring to ensure continuous peak e ciency and enhanced technical support. ProDx connects your ACL TOP testing
systems to our servers, enabling automated continuous monitoring and maximizing instrument uptime.
Continuous monitoring of ACL TOP testing Remote support for real-time, individually
system performance tailored service*
• Identifies issues quickly • Guided system software configuration
• Predicts unexpected system malfunctions and notifies • Fine-tuning and consultation
our Technical Support • System investigation and troubleshooting
• Live status monitoring and geographical location of instrument • Scheduled 1-on-1 operator training
• Increases uptime by optimizing preventative maintenance
• Historical data facilitates and expedites root-cause analysis
Maximize uptime for your instrument
• Flags potential problems early, supporting preventative actions
• Identifies root cause and facilitates rapid resolution
• Availability of real-time status information reduces service repair time
ProDx Device
SSL VPN Tunnel Proactive Diagnostic Secure Data Center/

Analysis and Technical Support and
Continuous Monitoring Service Specialists
ProDx Device
Customer Site/Hospital Network Our Network
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NEW
For Hemostasis testing—and for your specific needs

Advanced automation of the pre-analytical, analytical and post-analytical phases of Hemostasis testing in high-volume labs. Enhances
productivity, improves quality and reduces operating cost. HemoCell Specialized Lab Automation is a workcell solution
for Hemostasis testing, customized to your goals.
• Higher throughput • Retention of Hemostasis expertise in your lab
• Shorter turnaround times • Reduced operator exposure to biohazards
• Centralized control of Hemostasis testing • Low implementation impact in the laboratory
ACL TOP 750 LAS

Hemostasis Testing Systems
Thermo Scientific™
TCAutomation™
Laboratory HemoCell integrates the leading Hemostasis testing
Automation System system with the e ciency of lab automation.
HemoHub
Intelligent Data Manager
46
Configured for optimal performance
Following a custom analysis from IL, a personalized plan is designed to optimize workflow, analyzers and reagents throughout the track.
EsFlex Online centrifuge Decapper Recapper

• Input/output/sorter • User-configurable centrifugation • Traditional closures and screw caps • Universal conical cap
• Cap detection parameters decapped • Multi-tube capability
• Multiple centrifuges can • System identifies tube height and
be installed diameter, allowing use of a variety
of primary tube types
ACL TOP 750 LAS

• Seamless middleware integration and enhanced
automation features
HemosIL assay portfolio

• Routine and specialty testing directly from the track
HemoHub Intelligent Data Manager

• Results management, intelligent sample routing and
personalized KPIs to help monitor performance
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Consumables and Accessories

Consumables
ACL TOP Family/
Product P/N ACL Elite/Elite Pro ACL AcuStar
ACL TOP Family 50 Series
Cuvettes (2400 cuvettes) 0029400100 •
CTS filters (12/pkg) 0029403501 •
Rotors (100 pcs/2000 wells) 0006800000 •
Sample tray converter (3.5 mL) 0019058600 •
Sample tray (5 mL) 0018110898 •
Sample tray (S 11.5) 0018181285 •
ACL AcuStar cuvettes (1400 pcs) 0009801100 •
ACL AcuStar cuvette waste bin 0009801030 •
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Accessories
ACL TOP
ACL TOP 750 ACL TOP ACL TOP ACL TOP ACL Elite/
Product P/N 750 CTS
ACL TOP 750 LAS 550 CTS 350 CTS Elite Pro
ACL TOP CTS
Magnetic stirrers 0009746606 • • • • • •
Sample cups 0.5 mL
0006799200 •
(polystyrene 1000 pcs)
Sample cups 2 mL
0005575100 • • • • • •
(polystyrene 1000 pcs)
Sample cups 4 mL
0006799400 •
(polystyrene 100 pcs + labels)
T-connector 0007406800 •
Sample/reagent tubing 0007328901 •
Filter reagent cooling fan 00028617301 • • •
Filter reagent cooling fan 00027333801 •
Filter reagent cooling fan 00029520901 •
Air filter moulded 0018181271 •
Waste reservoir 0018181272 •
Needles block 0018110843 •
Needles adjustment tool 0018103941 •
Waste tube 0009909503 •
Waste bottle 0018105769 •
Waste bottle 0018901300 • • • • •
Glass vials 20 mL (8 pcs) 0019085463 • • • • •
Glass vials 10 mL (10 pcs) 0018924100 • • • • • •
Glass vials 4 mL (10 pcs) 0018924104 • • • • • •
Plastic bottle (30 mL) 0018902000 • • • • •
Tubing extractor kit 0018108065 •
Aliquot tube adapter (10 pcs) 0028533400 • • • • •
Paediatric tube adapter (10 pcs) 0028533500 • • • • •
Micro tube adapter (10 pcs) 0028533700 • • • • •
CTS sample tube adapter (10 pcs) 0028533600 • • •
CTS rack adapter blue (48/pkg) 0027500148 • • •
CTS rack adapter blue (96/pkg) 0027500149 • • •
50
ACL TOP
Product P/N 750 CTS
ACL TOP CTS
CTS piercer 0029403601 • • •
CTS probe 0029403701 • • •
CTS sample rack set, 01–12 0029400901 • • •
CTS filter replacement tool 0028386300 • • •
CTS Sarstedt rack set, 16.3 mm 01–08 0000051301 • • •
Sarstedt CTS racks and sample adapters may be used on any ACL TOP system with CTS (software version 4.0 or higher). Rack numbering and rack counts vary by set.
51
ACL TOP
Product P/N 750 CTS
ACL TOP CTS
CTS Sarstedt rack set, 14 mm 01–08 0000051401 • • •
ACL AcuStar Sample Rack (6 pcs) 0009801006 •
ACL AcuStar Sample Rack Adapters (30 pcs) 0009801020 •
ACL AcuStar Narrow Tube Adapters (30 pcs) 0009801025 •
Sample racks 0019007000 •
Sample rack set, 01–08* 0029400541 • • • • •
Sample rack set, 09–16* 0029400542 • • • • •
Sample rack set, 17–24* 0029400543 • • • • •
Sample rack set, 25–32* 0029400544 • • • • •
Sample rack set, 33–40* 0029400545 • • • • •
Sarstedt CTS racks and sample adapters may be used on any ACL TOP system with CTS (software version 4.0 or higher). Rack numbering and rack counts vary by set.
*Open tubes or cup. Rack sets compatible with all ACL TOP Family systems. Rack numbering and rack counts vary by set.
52
ACL TOP
Product P/N 750 CTS
ACL TOP CTS
Sample rack set, 41–48* 0029400546 • • • • •
Sample rack set, 49–56* 0029400547 • • • • •
Sample rack set, 57–64* 0029400548 • • • • •
4 mL diluent bottle adapter (2 pcs) 0028526001 • • • • •
Rotor insertion tool 0018181277 •
Reagent adapters 10 mL vial (stirred) 0018181265 •
Reagent adapters 10 mL vial (not stirred) 0019076200 •
Reagent adapters 4 mL vial (not stirred) 0019076100 •
Sample tray cup adapters 0019076400 •
Sample tray 4 mL vial adapters 0019076300 •
4 mL reagent bottle adapters 0028520500 • • • • •
10 mL reagent bottle adapters 0028520900 • • • • •
Reagent rack set, RA-RF 0029400601 • • • • •
Reagent rack set, RG-RM 0029400602 • • • • •
Rack set reagent, RA-RD ACL TOP 0029400641 • • • • •
Rack set reagent, RE-RH ACL TOP 0029400642 • • • • •
ACL TOP diluent rack set, DA-DB 0029400741 • • • • •
ACL TOP diluent rack set, DC-DD 0029400742 • • • • •
Diluent rack DA-DC 0029400701 • • • • •
Diluent rack DD-DF 0029400702 • • • • •
Sample rack set, 01–12* 0029400501 • • • • •
Sample rack set, 13–24* 0029400502 • • • • •
Sample rack set, 25–36* 0029400503 • • • • •
Sample rack set, 37–48* 0029400504 • • • • •
Sample rack set, 49–60* 0029400505 • • • • •
Sample rack set, 61–72* 0029400506 • • • • •
Sample rack set, 73–84* 0029400507 • • • • •
Sample rack set, 85–96* 0029400508 • • • • •
Cuvette waste liner, 10 pack (ACL TOP 500) 0029506900 •
Cuvette waste liner, 10 pack (ACL TOP 700) 0029401100 • • •
Cuvette waste bin, 10 pack (ACL TOP 300) 0027344900 •
Tray, 6-sample racks 0028780200 • • • • •
*Open tubes or cup. Rack sets compatible with all ACL TOP Family systems. Rack numbering and rack counts vary by set.
53
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Back To Index
Instrument Specifications/Tests
Instrument Specs/Tests
ACL TOP
ACL Elite/
Specifications 750 CTS ACL TOP 750 LAS ACL TOP 550 CTS ACL TOP 350 CTS ACL AcuStar
Elite Pro
ACL TOP CTS
Turbidimetric (clotting) channel • • • • •
Absorbance (chromogenic) channel • • • • •
Immunological tests • • • • • •†
Samples onboard (maximum) 120 90 80 40 40 30
Reagents onboard (maximum) 44 (+16) 44 (+16) 40 26 18/22 20
Cuvettes onboard (maximum) 800 800 800 800 240 280
Sample predilution • • • • • •
Calibration curve predilution • • • • •
STAT capability • • • • • •
Quality control • • • • • •
Patient data storage • • • • • •
Reaction curves availability • • • • •
Liquid (sample/reagent) sensor • • • • • •
Primary tube capability • • • • • •
External barcode reader * • * * * •
Internal barcode reader • • • • • •
Throughput up to PT/hour 360/270 240 110 150 ††
APTT/hour 320/270 180 110 100 ††
Automatic downloading • • • • • •
Automatic validation * * * * •
Automatic uploading * * * * • •
Automatic printing on internal printer • •
Automatic printing on external printer • • • • • •
Interface to host computer Bidirectional Bidirectional Bidirectional Bidirectional Bidirectional Bidirectional
Sample ID • • • • • •
Preheating • • • • •
Open applications • • • • •
Cap-piercing • • •
*Optional. †Chemiluminescent technology. †† ACL AcuStar throughput is 60 tests/hour. PT/APTT are not applicable. For supported assays, refer to page 56.
55
Back To Index
Instrument Specifications/Tests
Tests ACL TOP Family ACL Elite/Elite Pro ACL AcuStar
PT • •
PT-Fib based • •
APTT • •
TT • •
Fibrinogen-C • •
Pro-IL-Complex* • •
Hepatocomplex* • •
Heparin • •
Liquid Anti-Xa • •
D-Dimer • • •
D-Dimer 500* • •
D-Dimer HS •
D-Dimer HS 2000* •
D-Dimer HS 500 •
FDP* •
HIT-Ab(PF4-H) •
HIT-IgG(PF4-H) •
Antithrombin • •
Protein C (chromogenic) • •
ProClot (clotting) • •
Protein S Activity • •
Free Protein S • •
Factor V Leiden (APC-R V) • •
Homocysteine • •
dRVVT Screen & Confirm • •
Silica Clotting Time • •
Anti-Cardiolipin IgG •
Anti-Cardiolipin IgM •
Anti-β2 GPI Domain 1 •
Anti-β2 Glycoprotein-I IgM •
Anti-β2 Glycoprotein-I IgG •
Factor II (clotting) • •
Factor V (clotting) • •
Factor VII (clotting) • •
Factor VIII (clotting) • •
Factor IX (clotting) • •
Factor X (clotting) • •
Factor XI (clotting) • •
Factor XII (clotting) • •
Factor VIII (chromogenic) •
Factor XIII Antigen** •
von Willebrand Factor Antigen • • •
von Willebrand Factor Activity • •
von Willebrand Factor Ristocetin Cofactor Activity* • •
von Willebrand Factor Collagen Binding Activity* •
Plasminogen • •
Plasmin Inhibitor • •
**FXIII assays are exempt from 510(k)-clearance.
56
57
IL is passionate about bringing the most innovative solutions to Hemostasis testing. Offering a broad range of the highest quality instruments, data management solutions and a full panel of HemosIL®
assays—supported by a world-class technical team—IL is committed to enhancing patient care through continuous innovation.
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HIL.CAT v1 WW 11/18
Visit instrumentationlaboratory.com for the latest product list and package inserts,
available in English, French, German, Italian, Portuguese and Spanish.
The Instrumentation Laboratory logo, ACL, ACL AcuStar, ACL Elite, ACL TOP, HemoCell, HemoHub, HemosIL, ReadiPlasTin, RecombiPlasTin, SynthAFax and SynthASil are trademarks of Instrumentation Laboratory Company and/or one of its
subsidiaries or parent companies and may be registered in the United States Patent and Trademark Office and in other jurisdictions. All other product names, company names, marks, logos and symbols are trademarks of their respective owners.
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Catalog Hemostasis IL 2018-2019 EN

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2018-19 Hemostasis

Product Line Catalog

Only IL o ers industry-leading ACL TOP analyzers, HemosIL assays,

For more information, contact your local Werfen sales representative

General Screening and Anticoagulant

General Screening and Anticoagulant Monitoring/Measurement for Testing

ISIweb Software A web-based ISIweb software tool • Accessible through mywerfen.com

Fibrin Formation and Degradation

Fibrin Formation and Degradation/D-Dimer/Fibrinolysis

*For US and Canada.

Bleeding Disorders/Coagulation Factors

*FXIII antigen assays are exempt from 510(k)-clearance.

von Willebrand Disease

von Willebrand Disease

Heparin-Induced Thrombocytopenia (HIT)

Heparin-Induced Thrombocytopenia (HIT)

ProClot Diluent For the calibration and analysis 1 x 100 mL

Antiphospholipid Syndrome (APS)

Antiphospholipid Syndrome (APS)

*Not available in all countries.

Plasma Calibrators and Controls

Plasma Calibrators and Controls

Plasma Calibrators and Controls

*Not available in all countries.

Plasma Calibrators and Controls

ACL TOP Family/

Free Protein S Antigen • •

FVIII, IX, XI, XII • • •

Cleaning Solution (Clean A) Cleaning solution for ACL systems. 1 x 500 mL

Rinse Solution Rinsing solution for ACL TOP systems. 1 x 4000 mL

A breakthrough in Hemostasis testing

Advanced testing automation and quality management

Various configurations offer

Analyzer automation Continuous operation Fast turnaround

*The ACL TOP 50 Family Series is not available in all countries.

Advanced testing automation and quality management

Analyzer automation Continuous operation Fast turnaround

*The ACL TOP 50 Family Series is not available in all countries.

Advanced testing automation and quality management

Analyzer automation Continuous operation Fast turnaround

*The ACL TOP 50 Family Series is not available in all countries.

ACL Elite and ACL Elite Pro

Solutions for Hemostasis testing

Proactive vigilance for peak e ciency

SSL VPN Tunnel Proactive Diagnostic Secure Data Center/

Customer Site/Hospital Network Our Network

*Not available in all countries.

For Hemostasis testing—and for your speciﬁc needs

ACL TOP 750 LAS

EsFlex Online centrifuge Decapper Recapper

ACL TOP 750 LAS

HemosIL assay portfolio

HemoHub Intelligent Data Manager

Consumables and Accessories

CTS ﬁlters (12/pkg) 0029403501 •

Rotors (100 pcs/2000 wells) 0006800000 •

Sample tray converter (3.5 mL) 0019058600 •

Sample tray (5 mL) 0018110898 •

Sample tray (S 11.5) 0018181285 •

ACL AcuStar cuvettes (1400 pcs) 0009801100 •

ACL AcuStar cuvette waste bin 0009801030 •

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