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 21 088 0132
Certificate history
IVDD 21 088 0132 (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Withdrawn on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Withdrawn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 Saliva Rapid Test Card (Immunochromatography)
V-CHEK/DoCHEK 2019-nCoV Ag Saliva Rapid Test Card is a lateral flow immunoassay intended for the in vitro qualitative detection of N-protein antigen from 2019-nCoV in human saliva specimens. The Test Card can be used for individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 infection.
Types/Categories/Models:
V-CHEK (0699C8G001, 0699C8X001, 0699C8X005, 0699C8X020)
DoCHEK (0699A81001, 0699A82001, 0699A82005, 0699A82020)
1 test per bag, 1 test per box, 5 tests per box, 20 tests per box
Classification
Devices for self-testing
