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PAX8 (QR016)

by biocyc Biotechnologie GmbH & Co. KG Germany EUDAMED

Ref C-P008-05 EMDN W01030709

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number42555978ANTIBODYP0086C Basic UDI-DIDate8 Nov 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
C-P008-05
Primary DI / UDI-DI
04255597802070
Basic UDI-DI
42555978ANTIBODYP0086C
Direct Marketing DI
04255597802070
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

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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 34f0e91b-cc89-4757-ac71-18fb71085ef2 61 fields · synced 24 Oct 2026