Skip to content

Bioline™ Influenza Antigen

by Abbott Diagnostics Korea Inc. 4 variants

Ref AF19FK12AMVModel 19FK12

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800037005687 Basic UDI-DI 08800037005687UDI-DIDate21 Oct 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
19FK12, AF19FK12AMV
Primary DI / UDI-DI
08800037005687
Basic UDI-DI
B-08800037005687
EMDN Code
W0105099004 Influenza a and /or b - rt & poc
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
KR-MF-000025193
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Abbott Diagnostics Korea Inc.

See all devices from Abbott Diagnostics Korea Inc. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No