Decheng V-chek 2019-nCoV Ag Rapid Test Kit

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Certification scheme

98/79/EC Annex III section 6

Certificate number

IVDD 21 041 0104

Certificate history

IVDD 21 041 0104 (Initial issue | 22.Oct.2021)

Manufacturer/Holder of certificate

Guangzhou Decheng Biotechnology Co., Ltd

Room 218 and Room 212, Building 2, No. 68, Nanxiang 1st Road, Science City, Huangpu District, Guangzhou, Guangdong, 510663, P.R. China

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The manufacturer has a duty to submit to the Notified body testing results as per established procedure of each manufactured batch prior its releasing.

Products within scope

V-chek 2019-nCoV Ag Rapid Test Kit (Immunochromatography)


In vitro diagnostic medical device kit used for the in vitro qualitative detection of 2019-nCoV antigen. It is an immunochromatography sandwich assay, and intended to detect 2019- nCoV N- protein antigen in human nasal (NS) swab specimens. The kit can be used for individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection

1 test per box, 5 tests per box, 25 tests per box (0685C2X001, 0685C2X005, 0685C2X025)

Devices for self-testing