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: Finecare™ fT4 Rapid Quantitative Test
Catalog No: W259
LOT. NO.： F25916401AD
EXP. ： 2025/03/12

Characterization: The FinecareTM fT4 Rapid Quantitative Test is a fluorescence immunoassay

used along with FinecareTM FLA Meters (Model No.: FS-112, FS-113, FS-
114, FS-205) for quantitative determination of free thyroxine (fT4) in human
whole blood, serum or plasma. The test is used as an aid to the
assessment of thyroid function. For in vitro diagnostic use only. For
professional use only.

Performance: The FinecareTM fT4 Rapid Quantitative Test is based on fluoresence

immunoassay technology. It uses a competitive immunodetection method.
When sample is added into the sample well of the Test Cartridge, the
fluorescence-labeled detector fT4 antibodies bind to fT4 antigens in blood
specimen and form immune complexes. As the complexes migrate on the
nitrocellulose matrix by capillary action, it can't be captured by fT4 antigens
that have been immobilized on test strip. But the excess unbound
fluorescence-labeled detector fT4 antibodies are captured. Thus the more
fT4 in blood, the less unbound fluorescence-labeled antibodies
accumulated on test strip. Signal intensity of detector fT4 antibodies reflect
the amount of antigens and are processed in the FinecareTM FIA Meters to
determine the fT4 concentration in blood.

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.