Skip to content

QXDx BCR-ABL %IS Kit

by Bio-Rad Laboratories, Inc.

Ref 12006134

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 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number361052A005088C Basic UDI-DI 03610521171980UDI-DIDate22 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
ddPCR BCR-ABL
Model / Reference
12006134
Primary DI / UDI-DI
03610521171980
Basic UDI-DI
361052A005088C
EMDN Code
W01060299 Tests for acquired genetic or chromosomal alterations - other
Device Class
Class C
EU market of registration
France

Manufacturer details

EUDAMED SRN
US-MF-000020713
Authorised representative
Bio-Rad FR-AR-000006264

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Human Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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