Decheng V-chek 2019-nCoV Ag Rapid Test Kit

Certificate verification page

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

Other sites
Effective from

22.Oct.2021

Valid until

26.May.2022

Suspension period
Withdrawn on
Validity status
Valid
Validity conditions

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

Types/Categories/Models:
1 test per box, 5 tests per box, 25 tests per box (0685C2X001, 0685C2X005, 0685C2X025)
Classification

Devices for self-testing