ACtest_IVDD 21 077 0143

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 21 077 0143

Certificate history

IVDD 21 077 0143 (Initial issue |23.May.2022)

Manufacturer/Holder of certificate

ACtest Biotech (Hangzhou) Co., Ltd.

Room 408, Building 5, #600 Yinhai Street, Qiantang New Area, Hangzhou, P.R. China

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Products within scope

SARS-CoV-2 Antigen Rapid Test


SARS-CoV-2 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 viral nucleoprotein antigens in human nasal swab specimens. It is generally detectable in upper respiratory specimens during the acute phase of infection.


ACCOV-S01001 (1 test)
ACCOV-S01005 (5 tests)
ACCOV-S01025 (25 tests)


Devices for self-testing