Certificate verification page
Certification scheme
Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV excluding section 4 and section 6
Certificate number
IVDD 21 087 0131
Certificate history
IVDD 21 087 0131 (Initial issue |20.May.2022)
Manufacturer/Holder of certificate
Guangzhou Decheng Biotechnology Co., Ltd
Room 107, 212, 218, 405, Building 2, No.68, Nanxiang 1st Road, Science City, Huangpu District, Guangzhou, Guangdong, 510663 P.R. China
Other sites
Effective from
20.May.2022
Valid until
26.May.2025
Suspension period
15 May 2024 – 15 June 2024
Withdrawn on
16 June 2024
Validity status
Withdrawn
Validity conditions
–
Products within scope
2019-nCoV Ag Rapid Test Kit (Immunochromatography)
V-chek/ DoCHEK 2019-nCoV Ag Rapid Test Kit is 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:
V-chek (0685C2G001, 0685C2X001, 0685C2X005, 0685C2X025)
DoCHEK (0685C21001, 0685C22001, 0685C22005, 0685C22025)
1 test per bag, 1 test per box, 5 tests per box, 25 tests per box
Classification
Devices for self-testing
