Decheng_IVDD 21 087 0132

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
Withdrawn on
Validity status
Valid
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

 

 

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