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Fast
Reliable
Close to patients
Introduction.............................................................................................................................................. 4
Hematology ........................................................................................................................................... 19
Hemolyzer® 3 NG / 5 NG......................................................................................................................... 20
Hemolyzer® NG Products ....................................................................................................................... 22
Hemolyzer® Products ............................................................................................................................. 23
General conditions
Pictures Products are delivered on the general terms and conditions of Ana- to modify products at any time on behalf of further development.
Cover: www.stock.adobe.com
lyticon Biotechnologies AG only. Information stated in cata logues Product availability may vary from country to country and is subject
Inside pages: www.istockphoto.com
HA Hessen Agentur GmbH – Jan Michael Hosan and product flyers is provided only for informative p
urposes and does to varying regulatory requirements. Please contact your local repre-
Analyticon Biotechnologies AG MP2020_GB_61_001_01.01_20191202 not bind the seller. Analyticon Biotechnologies AG reserves the right sentative for availability.
2 3
Fast. Reliable. Close to patients.
Vision About us expectations of our customers and partners worldwide with high-
quality products for routine diagnostics, compelling solutions, and
Analyticon is an agile and global diagnostics company focused on
responsive service and support. We lay great value on listening to
Our vision is to develop and distribute customized solutions for urine diagnostics and hematology. Our
our customers, recognizing their needs, and translating them into
innovative urinalysis and hematology solutions products support accurate and cost-effective onsite diagnostics
innovative products and solutions.
for the in vitro diagnosis of diabetes, kidney in doctors’ offices, hospitals, and clinical laboratories. Analyticon
disease, and infectious diseases, among distributes products to more than 100 countries via a worldwide We continuously work to improve our products and services. Our
other medical conditions. In this way, we help network of partner companies and distributors. All products are internal processes are reviewed and optimized through frequent
improve patient quality of life around the world. manufactured according to DIN EN ISO 13485 and 9001 standards. dialog with our employees and customers. The thorough quality
assurance of all our operational processes is guaranteed by our
Analyticon is also a reliable OEM manufacturer for many interna-
certified quality management system, which complies with the inter-
tional IVD companies.
nationally valid standards DIN EN ISO 13485 and 9001. We assure
Mission Business areas
seamless and continuous quality control of development, produc-
tion, and distribution, and our products meet all quality standards of
With our focus on Point of Care Solutions Analyticon is dedicated the strict IVD Directive 98/79/EC.
Our mission is to provide the highest quality
to develop and distribute innovative urinalysis and hematology sys-
diagnostic systems and solutions that deliver Furthermore, Analyticon regularly participates in external ring trials
tems for the in vitro diagnosis of diabetes, kidney diseases and in-
accurate results while optimizing workflows to and has registered portions of its portfolio with national authori-
fectious diseases, among other medical conditions.
boost laboratory efficiency. ties (e.g., the Chinese National Medical Products Administration
Our Point of Care Solutions facilitate a fast and reliable diagnosis. (NMPA), Scandinavian Laboratory Equipment Assessment Author-
We make every effort to ensure that our solu-
This is achieved by ease of use, state of the art data management, ity (SKUP), College of American Pathologists (CAP)).
tions meet end-user needs but remain afford-
unique and intuitive user interface structures and a quality focused
able at all times and in any country.
development and production. Your Analyticon Team
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Urine Diagnostics
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®
CombiScreen Urine Test Strips
®
CombiScreen mALB / CREA
Application of urine test strips Easy-to-use • The albumin-to-creatinine ratio provides accurate in-
formation on albumin level in urine, regardless of the
Urine test strips are easy-to-use, cost-effective and The CombiScreen® urine test strips have a consistent urine concentration.
provide fast and reliable information on pathological reading time of 60 seconds (up to 120 for leucocytes). • The low detection limit of 20 mg/l albumin enables
changes in the organism. Urine test strips are intended The long handle end prevents contact with the test pads, reliable screening of risk patients.
to be used as a screening test for ensuring hygienic evaluation of the urine test strips. The • Cost-effective and fast method. No 24 h sample col-
aluminum vial sealed with a desiccant stopper protects lection is necessary.
• Kidney diseases and urinary tract infections
the strips from light as well as humidity and allows one-
• Metabolic disorders like diabetes mellitus
hand operation.
• Liver and hemolytic diseases
Furthermore, they are often used to monitor the success
of a prescribed therapy or to self-monitor the metabolic
situation of diabetic patients.
Distinct color changes in the clinically relevant Excellent ascorbic acid protection for glucose
range and blood pad
In order to obtain clear results, CombiScreen® urine Ascorbic acid (Vitamin C) is absorbed by food, n utritional
test strips show a distinct color change in the clinically supplements and as a preservative in the body. Excess
relevant range, which enables the differentiation between ascorbic acid is excreted; nevertheless, significant
normal and suspicious ascorbic acid levels in the urine are observed in a high
findings. Furthermore, proportion of the population.
the high sensitivity of our This can affect the sensitivity of conventional tests and
test pads shows clinically cause false negative results at high concentration levels.
significant results for each Due to that fact, necessary diagnostic or therapeu- A B C D E
parameter even at low tic actions might be delayed. CombiScreen® Crea
concentration levels (e.g. PLUS urine test strips are equipped with
10 50 100 200 300 mg/dL
the glucose pad will react an active protection of the glucose (0,9) (4,4) (8,8) (17,7) (26,5) (mmol/L)
already at 50 mg/dl). and blood test field, which effec- Intended Use
tively precludes interference Screening of microalbuminuria in people with chronic 1 2 3 4 5
by ascorbic acid. conditions, such as diabetes and high blood pressure
Alb
that puts them at an increased risk of developing a kid-
ney disease. It may also be associated with some lipid 10 30 80 150 500 mg/L
abnormalities and various immune disorders.
CREA
Precise
Four simple steps to achieve a multi-parameter result No 24h sample collection is necessary. The albumin-to- ALB A B C D E
creatinine ratio delivers information about the patient’s
urinary albumin concentration using a spontaneous
1
voided morning urine sample. 2
Easy-to-use 3
The included result table directly shows the diagnostic
relevant result. A calculation of the albumin-to-creati- 4
60 sec. incubation time nine ratio is not necessary. 5
• Collect the midstream speci- • Wipe off excessive urine at the • Dip the strip on a tissue and • Compare the color of the test Sensitive
men of urine (preferably morn- edge of the tube. keep it horizontal. Incubation pads with the label after 60
ing urine). time: 60 sec., Leucocytes up sec. In this example Glucose The detection limit of approx. 20 mg/l albumin offers a = Normal = High Abnormal
• Dip the strip about 2 sec. to 120 sec. and Ascorbic acid is positive. screening assay with high sensitivity.
• Take care all pads are wet. • Note the result.
Extended Albumin concentration range
= Abnormal = Recollect sample
Detection of microalbuminuria or macroalbuminuria by
the extended albumin concentration range The evaluation of the result is extremely simple and reli-
(up to 500 mg/L). able due to the table.
8 9
® ®
CombiScreen Parameter Overview CombiScreen Details
PLUS
Ascorbic Acid
Spec. Gravity
Nitrit PLUS Nit
Urobilinogen
– with ascorbic acid protection
Leucocytes
Creatinine
pH-Value
Glucose
Ketones
Albumin
Bilirubin
3 PLUS pH Glu Prot
Protein
Nitrite
Blood
Name Art.-No. Cont. 5+Leuko PLUS Glu Leu Nit Prot Uro Bld
3 93108 100
GAK 93107 100
GPK 93105 100 GP Prot Glu
5B 93134 100
3 pH Glu Prot
10SL 93120 / 93120A 100 / 150
11SYS2) 93100 / 93150 100 / 150 GAK Ket Asc Glu
1) ®
ystem test strips to be used with Urilyzer 100 Pro instruments
S
2)
System test strips to be used with CombiScan® and Urilyzer® 100/500 Pro instruments GPK Ket Prot Glu
3)
System test strips to be used with Urilyzer® Auto instruments
11SYS SG Leu Nit pH Bld Prot Glu Asc Ket Uro Bil
10 11
®
Urilyzer 100 Pro
The Urilyzer® 100 Pro is a semi-automated urine test strip analyzer for single test strip reading. The system is provided Easy-to-use Connectivity capabilities
with state-of-the-art operator and QC management as well as enhanced connectivity capabilities to meet the growing • A Start-Up Wizard leads the operator through the • Data can be transferred via serial connection or
demands for compliance management and data capture. The Urilyzer® 100 Pro including POCT features is unique in it’s user-defined settings upon first start of the device Ethernet
class. • Automatic start of the measurement after placing • A variety of interfaces for connecting external bar-
the urine test strip allows hygienic and clean opera- code scanner and/or keyboard (USB or PS2)
tion of the analyzer • Implemented protocols: HL7, LIS2 (ASTM+),
• Positive results, reminders and warnings are shown POCT1-A2
in color (e.g. red or yellow) and can be easily identi-
fied
• The user interface offers a high level of customiza- POCT1-A2 features
tion with flexible testing and reporting options • Ready to use with Siemens UniPOCTM and POC-
celeratorTM middleware*
• Remote configuration via middleware
Smart and safe operation • Automated synchronization of date and time via the
• Tracking of LOT-No. for urine test strips and quality middleware
control solutions • Messaging function allows the PoCT datamanager
• Data management provides multiple filter options to send messages to addressed operators or instru-
• QC ranges can be entered via QR-Code ments
• Automated QC analysis with customizable QC test • Positive Patient Identification (PPID)
reminders including lockout function • Remote software update
• System allows the allocation of different security • Test strip management
levels to individual users • QC solution management
• Proficiency test feature
* please contact us for other middleware options
Specifications
12 13
®
Urilyzer 500 Pro
The Urilyzer® 500 Pro is a semi-automated urine test strip analyzer with continous loading function. The system is Start-Up Wizard Easy-to-use
provided with state-of-the-art operator and QC management as well as enhanced connectivity capabilities to meet the • On first usage the operator can select the language. • Automatic strip detection (autostart)
growing demands for compliance management and data capture. Moreover, the system provides the user with a high Afterwards, the Start-Up Wizard leads through the • Easy-to-use software
level of customization with flexible testing and reporting options. user-defined settings • Color touchscreen operation
• The Start-Up Wizard enables the user to perform • High throughput of up to 500 tests/hour
measurements without having to go through the • Microscopy flag (sediment recommendation)
complete user manual • Standby function
• Minimal maintenance and convenient cleaning
Operator Management • Continuous loading system
• Multiple authorization levels
CombiScreen Control PN
• Programmable operator
Catalogmanagement
No. 93001 2 provides
x 15 ml cus- Lot No. V339
Exp. 2016/04
tomized access levels & prevents unauthorized use
1 x Power supply (AC adapter 100–240 V, 50/60 Hz) Autostart of measurement (automatic strip detection)
1 x Power supply cord *) Repeated dipping into the same container with test solution level 1 may cause false positives in nitrite and blood.
Automatic
**)In case of Urobilinogen, the levelprintout or atransfer
2 control generates of result
more orange-brownish colour on the test pad, compared to the colour on the label.
The Urilyzer® Auto is a newly designed fully automated CombiScreen® urine controls cover a wide range of analytes, including pregnancy markers and Microalbumin.
urine test strip analyzer introducing the pipetting technique The controls are designed for use in manual and automated methods, to monitor the performance of a variety of urine
in combination with a new measuring head to analyze the test strips.
CombiScreen® 11Auto urine test strip. In addition, the system
has a physical measurement cell module for determination of
specific gravity, color and turbidity.
CombiScreen® Dip Check Art.-No. 93010 CombiScreen® Drop Check Art.-No. 93015
16 17
Hematology
Innovative solutions
fitting your requirements
18 19
®
Hemolyzer 3 NG / 5 NG
AutosamplerArt.-No.: HE0350
suitable for Hemolyzer® 5 NG (closed); 50 positions
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® ®
Hemolyzer NG Products Hemolyzer Products
Reagent Hemolyzer® Art.-No. Kit size Reagent Hemolyzer® Art.-No. Kit size
H3-DIL 3 NG HE3251 5L Hemolyzer-Diluent 3 / 3 Pro / 5 HE3201 20 L
H3-DIL 3 NG HE3211 10 L Hemolyzer-3-Lyser 3 / 3 Pro HE3101 1L
H3-LYSE 3 NG HE3111 1L Hemolyzer-3-Cleaner 3 / 3 Pro HE3301 1L
H3/5-CLEAN 3 NG / 5 NG open HE3311 1L Hemolyzer-3-Cleaner 3 / 3 Pro HE3302 5L
H3/5-CLEAN 3 NG / 5 NG open HE3351 5L Hemolyzer-5-Lyser 5 HE5101 5L
H5-DIL 5 NG open/closed HE5251 5L Hemolyzer-5-Diff 5P 5 HE5201 1L
H5-DIL 5 NG open/closed HE5211 10 L Controls & Calibrators Hemolyzer® Art.-No. Kit size
H5-LYSE 5 NG HE5111 1L Hemolyzer-3-Control Set 3 / 3 Pro HE3502 2x3x3 ml
H5-CLEAN 5 NG closed HE5311 0.5 L (low, normal, high level)
H3-Compact 100 3 NG HE3701 100 tests Hemolyzer-3-Control Normal 3 / 3 Pro HE3503 6x3 ml
(Reagent pack: Diluent, Lyse, Cleaner) (level N)
H5-Compact 100 5 NG closed HE5701 100 tests Hemolyzer-5-Control Normal 5 HE5503 6x3 ml
(Reagent pack: Diluent, Lyse, Cleaner) (level N)
H5-Compact 400 5 NG closed HE5704 400 tests Hemolyzer-Calibrator 3 / 3 Pro / 5 HE3601 2x3 ml
(Reagent pack: Diluent, Lyse, Cleaner) Consumables Hemolyzer® Art.-No. Kit size
H5-Compact 100-O 5 NG open HE5707 100 tests Hemolyzer-Hypocleaner 3 / 3 Pro / 5 HE3401 100 ml
(Reagent pack: Diluent, Lyse, Cleaner)
Thermal printer paper (57 mm x 25 m) 3 / 3 Pro A93010 1 pcs.
H5-Compact 250-O 5 NG open HE5709 250 tests
(Reagent pack: Diluent, Lyse, Cleaner)
Controls & Calibrators Hemolyzer® NG Art.-No. Kit size
H3-Check Complete 3 NG HE3504 6x2.5 ml
(low, normal, high level)
H3-Check Normal 3 NG HE3505 6x2.5 ml
(normal level)
H5-Check Complete 5 NG open/closed HE5504 6x3 ml
(low, normal, high level)
H5-Check Normal 5 NG open/closed HE5505 6x3 ml
(normal level)
H3/5-Cal 3 NG / 5 NG open/closed HE3611 2.5 ml
Consumables Hemolyzer® NG Art.-No. Kit size
H3/5-Hypoclean 3 NG / 5 NG open/closed HE3412 100 ml
H3/5-Hypoclean 3 NG / 5 NG open/closed HE3411 1L
22 23
Fast. Reliable. Close to Patients.
MP2020_GB_61_001_01.01_20191202
Distributor information
Analyticon Biotechnologies AG
Am Muehlenberg 10
35104 Lichtenfels - Germany
Phone: +49 64 54 79 91-0
info@analyticon-diagnostics.com
www.analyticon-diagnostics.com