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Cytokeratin 18 (QR147)

by biocyc Biotechnologie GmbH & Co. KG Germany EUDAMED

Ref P-C054-70

EMDN W01030709

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42555978ANTIBODYC0543Q Basic UDI-DIDate4 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
P-C054-70
Primary DI / UDI-DI
04255597805477
Basic UDI-DI
42555978ANTIBODYC0543Q
Direct Marketing DI
04255597805477
EMDN Code
W01030709 Primary antisera for immunohistology
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000031533

Other devices from biocyc Biotechnologie GmbH & Co. KG

See all devices from biocyc Biotechnologie GmbH & Co. KG →

Properties & raw data

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

Sources (1)

  • EUDAMED ad740157-2f1d-44e0-b2dc-b0a8ed7ea7e2 61 fields · synced 22 Oct 2026