Prognosis_IVDD 21 070 0146

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 21 070 0146

Certificate history

IVDD 21 070 0146 (Initial issue | 25.May.2022)

Manufacturer/Holder of certificate

Prognosis Biotech S.A.

Farsalon 153, 41335, Larissa, Greece

Other sites
Ierea Panagioti Karatasiou 1, 542 50 Thessaloniki, Greece
Effective from


Valid until


Suspension period
Withdrawn on
Validity status
Validity conditions

Products within scope

Home Test COVID-19 Ag


Home Test COVID-19 Ag is a fast qualitative lateral flow immunoassay designed to detect the presence or absence of nucleocapsid protein of SARS-CoV-2 in nasal swab specimens directly collected in the first seven days from the onset of the symptoms.


H1301, H1302, H1305, H1320
1 test/package, 2 tests/package, 5 tests/package, 20 tests/package


Devices for self-testing