19 COA 03-07 REV01

CERTIFICATE OF ANALYSIS

3520101 Plasma Control Level 1 10x1 mL LOT

3520201 Plasma Control Level 2 10x1 mL LOT 35212 2019-11

2-8ºC IVD

QUALITATIVE CONTROLS

TEST SPECIFICATIONS RESULTS

APPEARANCE Lyophilised PASS x FAIL
SOLUBILITY SPEED < 2 Minutes PASS X FAIL

HBs Ag, Anti-HIV 1/2 and Anti HCV

HUMAN SOURCE PLASMA
Nonreactive when units tested individually.
STORAGE TEMPERATURE Refrigerate 2-8ºC.
STABILITY The expiry date is illustrated on the side of each pack.
Because no test method can offer complete assurance that
products derived from human source will not transmit infectious
SAFETY
agents, it is recommended that this product be handled with the
same precautions used for patients specimens.
Use of this product is only recommended together with the
USE enclosed batch specific document which contains analytical data
and stability information.

This lot was assayed by the test method described in the manufacturer's package insert.
These results are applicable to this lot and subsequent sublots, for which a capital letter has been assigned after the lot
number.
This Certificate of Analysis is a computer printout and has therefore not been signed by hand.
Signed
APPROVED Date of Manufacture:
This lot meets our specifications and is
released for sale
Mercè Oriol
(APPROVED / NOT APPROVED) 14 September 2017
Quality Control Dept.

QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS, S.L.U. Joaquim Costa 18 2ª planta. 08390 Montgat (Barcelona) SPAIN
ISO 9001 ISO 13485 Telf. (+34) 934 694 990; E-mail: info@linear.es ; website: www.linear.es NIF-VAT:B60485687