Guangzhou Wondfo Biotech Co., Ltd.

No. 8 Lizhishan Road, Science City, Luogang District, 510663,

Guangzhou, P.R. China
Tel: 86-20-32296083 Fax: 86-20-32296063
Website: en.wondfo.com.cn E-mail: Finecare@wondfo.com.cn

CERTIFICATE OF ANALYSIS
PRODUCT: FinecareTM D-Dimer Rapid Quantitative Test
Catalog No: W211
LOT. NO.： F21117507AD
EXP. ： 2025/03/20

Characterization: D-Dimer is the main and smallest product of Fibrin degradation, D-Dimer
fragments can be measured easily in plasma and whole blood, and the
presence or absence of D-Dimer may be useful in the diagnostic evaluation
of venous thromboembolism. D-Dimer Rapid Quantitative Test Cartridge
adopts fluorescence immunoassay technology and is intended for in vitro
quantitative determination of D-Dimer in human whole blood or plasma.

Performance: When sample is added to the sample well of the test, the
fluorescence-labeled detector anti-D-Dimer on the membrane binds to
D-Dimer antigen in whole blood/plasma specimen. As the sample mixture
migrates on the nitrocellulose matrix of test strip by capillary action, the
complexes of detector antibody and D-Dimer are captured by D-Dimer
antibody that has been immobilized on test strip. Thus the more D-Dimer
antigen is in whole blood/plasma specimen, the more complexes are
accumulated on test strip. Signal intensity of fluorescence of detector
antibody reflects amount of D-Dimer captured and FinecareTM FIA Meter
shows D-Dimer concentrations in whole blood/plasma specimen. The
default results unit of D-Dimer Test is displayed as XXX mg/L from
FinecareTM FIA Meter.

Package: Packaging procedure strictly follows the production manual and packaging
control is carried out by the quality control system. Inner package: Sealed
pouch contains 1 test. Outer package: kit size of outer package is variable.

Expiry: The device is stable for 24 months from the manufactured date.

Storage: The buffer and test cartridge should be stored at temperature of 4～30℃.

Precaution: The product is offered without warranty for any other specific use than that
specified in the instruction of use.
Product approved and released based on information gained from manufacturer by:

Quality Manager
Guangzhou Wondfo Biotech Co., Ltd.