Certificate verification page
Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Annex IV excluding section 4 and section 6
IVDD 21 070 0146
IVDD 21 070 0146 (Initial issue | 25.May.2022)
Manufacturer/Holder of certificate
Prognosis Biotech S.A.
Farsalon 153, 41335, Larissa, Greece
Ierea Panagioti Karatasiou 1, 542 50 Thessaloniki, Greece
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