Siemens Healthcare Diagnostics Products GmbH Certificate of Analysis

Emil-von-Behring-Str. 76
P.O.
35041 Marburg
Material: Commission-No.
Germany
10446063
Kit-Lot: Customer-Order-No.
567286A
Total lot size: Customer-No.
570 PC
Delivery amount: Storage at:
+02°C to 08°C
Release date:
2021-09-29
Customer
Manufacturing date: Expiration date:
To whom it may concern
2021-08-10 2023-02-09
Legal Material Number:
OQGP17
Released by:
Stefan Barth

Material: 10446063
LA 1 SCREENING REAGENT 10 X 2.0 ml
Inspection ID-No.: 400000507270
_______________________________________________________________________

Kit components:
Level Material-No. Lot Release date
Material-Name
_______________________________________________________________________
0010 11523862 567286A 2021-09-22
LA 1 Screening Reagent
_______________________________________________________________________

Page 01 from 03
Print date 2021-09-30
Material: 10446063
LA 1 SCREENING REAGENT 10 X 2.0 ml
Inspection ID-No.: 400000507270
_______________________________________________________________________

Inspection results:
Material-No. Lot
_______________________________________________________________________

10446063 567286A
LA 1 SCREENING REAGENT 10 X 2.0 ml
_______________________________________________________________________
_______________________________________________________________________

Visual Evaluation LA1

Visible control of the trial sample. After dissolving, the reagent should be a clear, green-colored liquid, which may
not exhibit any impurities.
_______________________________________________________________________

Visual evaluation

Result Unit Assigned Value Upper Limit Lower Limit

meets requirements - - -
_______________________________________________________________________
_______________________________________________________________________

_______________________________________________________________________

Barcode verification
Verification of the legibility of the barcode.

Result Unit Assigned Value Upper Limit Lower Limit

OKAY - - -

Page 02 from 03
Print date 2021-09-30
Material: 10446063
LA 1 SCREENING REAGENT 10 X 2.0 ml
Inspection ID-No.: 400000507270
_______________________________________________________________________

Material-No. Lot
_______________________________________________________________________

11523862 567286A
LA 1 Screening Reagent

Verification of the certificate

Result Unit Assigned Value Upper Limit Lower Limit

meets requirements - - -
_______________________________________________________________________

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.

Page 03 from 03
Print date 2021-09-30