Decheng_IVDD 21 087 0131

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
Withdrawn on
Validity status
Suspended
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

 

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