Siemens Healthcare Diagnostics Products GmbH Certificate of Analysis

Emil-von-Behring-Str. 76
P.O.
35041 Marburg
Material: Commission-No.
Germany
10484203
Kit-Lot: Customer-Order-No.
556739C
Total lot size: Customer-No.
3665 PC
Delivery amount: Storage at:
+02°C to 08°C
Release date:
2022-09-15
Customer
Manufacturing date: Expiration date:
To whom it may concern
2022-06-13 2024-06-12
Legal Material Number:
10484203
Released by:
Stefan Barth

Material: 10484203
KONTROLL-PLASMA P 10XF.1M
Inspection ID-No.: 400000583492
_______________________________________________________________________

Kit components:
Level Material-No. Lot Release date
Material-Name
_______________________________________________________________________
0010 11530361 556739 2022-08-22
Control Plasma P
_______________________________________________________________________

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Print date 2022-09-16
Material: 10484203
KONTROLL-PLASMA P 10XF.1M
Inspection ID-No.: 400000583492
_______________________________________________________________________

Inspection results:
Material-No. Lot
_______________________________________________________________________

11530361 556739
Control Plasma P
_______________________________________________________________________
_______________________________________________________________________

PT with Thromborel S
Creation of a reference curve with PT Multi Calibrator with Thromborel S, with subsequent measurement of the
test lot which is to be approved.
_______________________________________________________________________

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

31.6 % - 39.1 % 26.1 %
_______________________________________________________________________
_______________________________________________________________________

Fibrinogen with Multifibren U

Creation of a reference curve with Fibrinogen Calibrator Kit and with Multifibren U, with subsequent measurement
of the lot which is to be approved.
_______________________________________________________________________

Control plasma P

Result Unit Assigned Value Upper Limit Lower Limit

1.0 g/l - 1.3 g/l 0.5 g/l
_______________________________________________________________________
_______________________________________________________________________

AT III with BC AT III (A)

Creation of a reference curve with Standard Human Plasma and Berichrom AT III, with subsequent measurement of
the test lot which is to be approved.
_______________________________________________________________________

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

34.7 % - 41.0 % 25.0 %

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Print date 2022-09-16
Material: 10484203
KONTROLL-PLASMA P 10XF.1M
Inspection ID-No.: 400000583492
_______________________________________________________________________

Material-No. Lot
_______________________________________________________________________

11530361 556739
Control Plasma P
_______________________________________________________________________
_______________________________________________________________________

APTT with Pathromtin SL

Determination of APTT with Pathromtin SL.
_______________________________________________________________________

Control Plasma P

Result Unit Assigned Value Upper Limit Lower Limit

96.2 S - 109.9 S 73.3 S
_______________________________________________________________________
_______________________________________________________________________

_______________________________________________________________________

Test material: Thromborel S

Result Unit Assigned Value Upper Limit Lower Limit

Used - - -
Inspection remark 565742

Test material: Multifibren U

Result Unit Assigned Value Upper Limit Lower Limit

Used - - -
Inspection remark 539068

Test material: Berichrom AT III (A)

Result Unit Assigned Value Upper Limit Lower Limit

Used - - -
Inspection remark 00952

Test material: Pathromtin SL

Result Unit Assigned Value Upper Limit Lower Limit

Used - - -
Inspection remark
536736
_______________________________________________________________________

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Print date 2022-09-16
This document was generated by means of electronic data system, which was designed and
validated to comply with the FDA21 CFR Part 11 electronic records and signature. This
document indicates an electronic signature for batch release.
This lot has been tested and approved for release and shipment by the responsible Siemens
Healthcare Diagnostics Quality department.

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Print date 2022-09-16