Skip to content

TRUPCR® BCR-ABL Kit – Qualitative Major & Minor

by 3B BlackBio Dx Limited 3 variants

Ref 3B1204

Active European Union

CE IVDR

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/IVDR Number89080153043B1203KN Basic UDI-DI 08906213930177UDI-DIDate27 Jun 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
3B1204
Primary DI / UDI-DI
08906213930177
Basic UDI-DI
89080153043B1203KN
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
IN-MF-000023698
Authorised representative
Wellkang Ltd XI-AR-000001836

From the manufacturer

Manufacturer's product page: NPM1 Mutations Qualitative

Other devices from 3B BlackBio Dx Limited

See all devices from 3B BlackBio Dx Limited →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

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