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Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma)

by Zhejiang Orient Gene Biotech Co., Ltd EUDAMED

Active European Union

Ref GCTB-302a

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GCTB-302aZC Basic UDI-DIDate9 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  • Withdrawn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

Model / Reference
GCTB-302a
Primary DI / UDI-DI
D-GCTB-302aZC
Basic UDI-DI
B-GCTB-302aZC
EMDN Code
W0105011799 Bacteriology immunoassay - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhejiang Orient Gene Biotech Co., Ltd.

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Properties

Show properties
  • 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