Skip to content

BCR/ABL gene fusion detection probe

by Oacp Ie Ltd Ireland EUDAMED

Ref FP-003

EMDN W01030703

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-5391540380FP-003SQ58 Basic UDI-DIDate20 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
BCR/ABL gene fusion detection probe
Model / Reference
FP-003
Primary DI / UDI-DI
D-5391540380FP-003SQ58
Basic UDI-DI
B-5391540380FP-003SQ58
EMDN Code
W01030703 DNA in situ hybridisation reagents
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IE-MF-000003506

Other devices from Oacp Ie Ltd

See all devices from Oacp Ie Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 3469d69b-ee39-4a21-91bf-154ddad26632 61 fields · synced 22 Oct 2026