MANUFACTURED BY: “Certificate of Analysis”

KIMBALL ELECTRONICS POLAND SP. Z O.O. PRODUCT DESCRIPTION: MULTISTIX 10SG 100S
UL. POZNAŃSKA 1C RU/RS/BG/CZ 10318865
TARNOWO PODGÓRNE, 62-080 MATERIAL/CATALOG NO. A2300D40
LOT NO. /SERIAL NUMBER 104012
EXPIRATION DATE: 2022-09-30
(YYYY-MM-DD)
CUSTOMER
SIEMENS
MANUFACTURED DATE: 2021-03-29
(YYYY-MM-DD)

RELEASED BY: HANNA KRZYMIŃSKA

(NAME OF INDIVIDUAL)
HKRZYMI HAS CREATED THIS
RELEASED BY: DOCUMENT. DATE: APR 21 2021
(SIGNATURE) 12:31PM

This product was certified by the responsible Quality organization to conform to the performance requirements of Siemens
Healthcare Diagnostics. This product has been approved for shipment. Retain samples are held at the manufacturing site until
the date of expiration.

SEMI FINISHED PRODUCT DESCRIPTION: BOTTLED MULTISTIX 10 SG 100S PHIV SUB

MATERIAL/CATALOG NO. T2300BB
PRODUCTION BATCH NO. 0307451747
 REPORT OF ANALYSIS (URINE STRIPS)
Product name: BOTTLED MULTISTIX 10 SG 100S PHIV Sample number: 202104_R_006
SUB Supplementary Sample No: N/A
Product Code: T2300BB Method Numbers: MJ30-006, MJ30-007, MJ30-008, MJ30-
Specification Number: T2300BB 013, MJ30-178, MJ30-021, MJ30-028, MJ30-011
Lamination Batch No.: 0307443890 Customer Batch No.: 104012
SFC Batch Number: 0307451747

Test Name Result Specification Pass / Fail

Ct 50 Reagent Level limits
/Visual/Other(*)
CT50 BILI 0 mg/dL 1067 Min. 1024; n=18 Pass
CT50 BILI 0,8 mg/dL 922 Max .953; n=18 Pass
CT50 KET 0 mg/dL 715 Min. 666; n=18 Pass
CT50 KET 10 mg/dL 382 Max .466; n=18 Pass
CT50 NIT 0 mg/dL 923 Min. 909; n=18 Pass
CT50 NIT 0,15 mg/dL 784 Max .815; n=18 Pass
CT50 PH 7,0 553 427 - 726; n=18 Pass
CT50 PRO 0 mg/dL 967 Min. 890; n=18 Pass
CT50 PRO 30 mg/dL 664 Max .706; n=18 Pass
CT50 QNG 0 (2) mg/dL 783 Min. 742; n=18 Pass
CT50 QNG 100 (2) mg/dL 512 Max .593; n=18 Pass
CT50 QNG 250 (2) mg/dL 373 Max .456; n=18 Pass
CT50 QNG 250 (1) mg/dL 480 Min. 428; n=18 Pass
CT50 SG 1,010 988 SAS specification limit Pass
693-1068 n=18
CT50 SG 1,020 1532 1159 - 1679; n=18 Pass
CT50 URO 4,0 mg/dL 499 Max .543; n=18 Pass
CT50 URO 1,0 mg/dL 675 Min. 646; n=18 Pass
CT50 WBC 0 cells/µL 967 Min. 888; n=18 Pass
CT50 WBC 42 cells/µL 588 Max .706; n=18 Pass
CT50 OB 0 mg/dL 722 Min. 604; n=18 Pass
CT50 OB 0,0451 mg/dL 292 Max .372; n=18 Pass
CT50 OB 0,0621 mg/dL 274 Max .338; n=18 Pass
CT50 IR BAND BC1 - IR 33,5 30 - 46.5%; Pass
(30,0% - 46,5%; No
individual values are less

Page 2 of 4
Print Date 2021-04-21
 REPORT OF ANALYSIS (URINE STRIPS)
Product name: BOTTLED MULTISTIX 10 SG 100S PHIV Sample number: 202104_R_006
SUB Supplementary Sample No: N/A
Product Code: T2300BB Method Numbers: MJ30-006, MJ30-007, MJ30-008, MJ30-
Specification Number: T2300BB 013, MJ30-178, MJ30-021, MJ30-028, MJ30-011
Lamination Batch No.: 0307443890 Customer Batch No.: 104012
SFC Batch Number: 0307451747

Test Name Result Specification Pass / Fail

Ct 50 Reagent Level limits
/Visual/Other(*)
than 25,0% R or greater
than 50,0% R); n=18
CT50 IR BAND BC1 - RED 81,0 Min. 58.5%; n=18 Pass
CT50 IR BAND BC1 - GREEN 75,5 Min. 58%; Pass
(Min. 58,0%); n=18
CT50 IR BAND BC1 - BLUE 65,6 Min. 60%; Pass
(Min. 60,0%); n=18
VISUAL OB 0 mg/dL 10; Max. 10; Pass
SD 0 SD Max. 0; n=18
VISUAL OB 0,0451 mg/dL 34; 26 - 40; Pass
SD 0 SD Max. 5; n=18
VISUAL OB 0,0621 mg/dL 36; 28 - 40; Pass
SD 0 SD Max. 5; n=18
VISUAL QNG 0 mg/dL 10; Max. 10; Pass
SD 0 SD Max. 0; n=15
VISUAL QNG 100 mg/dL 20; 18 - 24; Pass
SD 1 SD Max. 3; n=15
VISUAL QNG 250 mg/dL 27; 22 - 30; Pass
SD 1 SD Max. 3; n=15
VISUAL WBC 0 cells/µL 10; 10 - 11; Pass
SD 0 SD Max. 1; n=15
VISUAL WBC 42 cells/µL 38 30 - 47; n=15 Pass
Appearance N/A N/A Complies Complies Pass
Desiccant N/A N/A Complies Complies Pass
Genaral N/A N/A Complies Complies Pass
inspection

Page 3 of 4
Print Date 2021-04-21
 REPORT OF ANALYSIS (URINE STRIPS)
Product name: BOTTLED MULTISTIX 10 SG 100S PHIV Sample number: 202104_R_006
SUB Supplementary Sample No: N/A
Product Code: T2300BB Method Numbers: MJ30-006, MJ30-007, MJ30-008, MJ30-
Specification Number: T2300BB 013, MJ30-178, MJ30-021, MJ30-028, MJ30-011
Lamination Batch No.: 0307443890 Customer Batch No.: 104012
SFC Batch Number: 0307451747

Test Name Result Specification Pass / Fail

Ct 50 Reagent Level limits
/Visual/Other(*)
Orientation from N/A N/A Complies Complies Pass
TIP

Ct 50 Reagent Result Comment User Date And Time

/Visual/Other(*)

CT50 IR BAND 33,5 All values not less than Katarzyna Wiśniewska 2021-04-02 13:54:24
25,0% R and not greater
than 50,0% R.

Test performed by: Aneta Mullak Date: 2021-04-02 Signature: amullak has created this document. Date: Apr 2 2021 12:34PM
Test checked by: Krzysztof Stachowski Date: 2021-04-06 Signature: krstach has approved this document. Date: Apr 6 2021 7:59AM

Page 4 of 4
Print Date 2021-04-21