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)
Confirmation letter on change (25 November 2023)

Manufacturer/Holder of certificate

Prognosis Biotech S.A.

Farsalon 153, 41335, Larissa, Greece

Other sites

Ierea Panagioti Karatasiou 1, 542 50 Thessaloniki, Greece
3rd km Larissis – Athinon regional national road, 41500 Larissa, Greece

Effective from


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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