Skip to content

Panbio™

by Abbott Rapid Diagnostics Jena GmbH 25 variants

Ref 41FK81Model AF41FK81GP, AF41FK81R, AF41FK81V, AF41FK81CP, AF41FK81HP, AF41FK81H, AF41FK81C

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 linked in EUDAMED

A group certificate may exist

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-04051892007260 Basic UDI-DI Date9 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
AF41FK81GP, 41FK81, AF41FK81R, AF41FK81V, AF41FK81CP, AF41FK81HP, AF41FK81H, AF41FK81C
Primary DI / UDI-DI
04051892007260, 04051892002593, 04051892003095, 04051892007024, 04051892007345, 04051892001879, 04051892001534
Basic UDI-DI
B-04051892007260, B-04051892002593, B-04051892003095, B-04051892007024, B-04051892007345, B-04051892001879, B-04051892001534
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD devices for self-testing
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
DE-MF-000025986

Other devices from Abbott Rapid Diagnostics Jena GmbH

See all devices from Abbott Rapid Diagnostics Jena GmbH →

Properties

  • Self Testing

Other properties (10)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No