Skip to content

Bioline™ Salmonella typhi IgG/IgM Fast

by Abbott Diagnostics Korea Inc. 2 variants

Ref AF15FK12PTModel 15FK12

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800037008978 Basic UDI-DI 08800037008978UDI-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  • Withdrawn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
15FK12, AF15FK12PT
Primary DI / UDI-DI
08800037008978
Basic UDI-DI
B-08800037008978
EMDN Code
W0105011002 Salmonella antibody assays
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

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (7)

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