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T-Spot.tb

by Oxford Immunotec Ltd EUDAMED

Active European Union

Ref TB.300

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5051716TBRB Basic UDI-DIDate19 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

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.

Specification

EUDAMED

Model / Reference
TB.300
Primary DI / UDI-DI
05051716000018
Basic UDI-DI
5051716TBRB
EMDN Code
W0105010704 Tb-igra (interferon-gamma-release assay)
Device Class
Class C
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
GB-MF-000004429
Authorised representative
Wallac Oy FI-AR-000044744

Other devices from Oxford Immunotec Ltd

See all devices from Oxford Immunotec Ltd →

Properties

  • Human Tissues
  • Animal Tissues
  • Professional Testing

Other properties (8)

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