Abacus Diagnostica Oy
FI-MF-000024114 · Finland · Turku
Abacus Diagnostica Oy is registered in the European database on medical devices as a manufacturer, with 25 devices declared. It was not found in the U.S. FDA device establishment register.
What this manufacturer declares
Most frequent device types declared: CDX-100, CDX-130, CDX-140, CDX-150, CDX-160.
Devices declared under this manufacturer
- GenomEra HSV 1/2, VZV + EV Assay Kit
- GenomEra Norovirus Assay kit
- GenomEra® C. difficile Assay Kit
- GenomEra® C. difficile Control Set
- GenomEra® GBS Assay Kit
- GenomEra® MRSA/SA AC Assay Kit
- GenomEra® MRSA/SA Multi Swab Assay Kit
- GenomEra® S. pneumoniae Assay Kit
- GenomEra® SARS-CoV-2 2.0 Assay Kit
- GenomEra® SARS-CoV-2 Assay Kit
- GenomEra® SARS-CoV-2, Flu A/B + RSV 2.0 Assay Kit
- GenomEra® SARS-CoV-2, Flu A/B + RSV Assay Kit
Showing 12 of 25 declared devices.
Catalogue references include CDX-100-01-40, CDX-140-01-20, CDX-140-01-40, CDX-160-01-100, CDX-170-01-20, CDX-170-01-40.
European nomenclature codes declared: W0105070302, W0105040519, W0105011804, W0105011203, W0105040516, W0105011105.
United States market access
| FDA establishment register | Not found in the FDA register |
|---|---|
| Devices in EUDAMED | 25 |
| Country of registration | Finland |
⚠️ Not found is not the same as not sold — how this comparison can be wrong.
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: Neither register. Abacus Diagnostica Oy was not found in either the U.S. or the Canadian register.