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Withdrawn on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
Replaced
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:
Classification
Devices for self-testing
