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Tuberculosis Interferon-Gamma Release Assay Test Kit (CLIA)

by Healgen Life Science, LLC United States EUDAMED

Ref CCTBIG-401a EMDN W0105010704

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-20850076346441 Basic UDI-DIDate20 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
CCTBIG-401a
Primary DI / UDI-DI
20850076346441
Basic UDI-DI
B-20850076346441
EMDN Code
W0105010704 Tb-igra (interferon-gamma-release assay)
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000043017
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Life Science LLC

See all devices from Healgen Life Science LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED b7f28335-3ca2-432d-8d5e-e4034951f85e 61 fields · synced 25 Oct 2026