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 Name: Finecare™ Vitamin D Rapid Quantitative Test
Catalog No: W241P0002
LOT: F2411650FBD
EXP. ： 2024/08/15
Characterization: The Finecare™ Vitamin D Rapid Quantitative Test along with Finecare™ FIA Meters
(Model No.: FS-112/FS-113/FS-205) is a fluorescence immunoassay for quantitative
determination of total 25(OH) D2/D3 level in human serum or plasma specimen. The
results are used in conjunction with other clinical and laboratory data to assist the
clinician in the assessment of vitamin D deficiency. For in vitro diagnostic use only.
For professional use only.

Performance: This assay is based on competitive fluorescent immunoassay technology. When

specimen is mixed with reconstituted marker, the 25 (OH) D in the specimen binds
to the fluorescent-labeled detection antibody, to form the complex as sample mixture.
When the sample mixture is added into the sample well of the Test Cartridge, the
excessive fluorescent-labeled antibody moves forward to the test line by capillary
action and combines with the 25 (OH) D which is immobilized on test strip. The more
25 (OH) D in blood specimen, the less fluorescent-labeled antibody accumulated on
the test strip. Signal intensity of fluorescence of detector antibody reflects amount of
25 (OH) D captured and FinecareTM FIA Meters shows 25 (OH) D concentrations in
blood specimen. The signal is inversely proportional to the 25 (OH) D concentration.
The default result unit of this test is displayed as XX. XX ng / mL from FinecareTM FIA
Meters.

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.