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Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody 468R-18

by Cell Marque Corporation

Ref 468R-18Model 468R-1X series

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number008416831468R-1FG Basic UDI-DI 04061841853732UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04061841853732 UDI-DI Date24 Nov 2020ListedStatusListed GUDID: not in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Claudin-4 (EP417) Rabbit Monoclonal Primary Antibody
Generic Name
Claudin protein IVD, antibody
Model / Reference
468R-18, 468R-1X series
Primary DI / UDI-DI
04061841853732 EUDAMED
00841683151623 GUDID
Basic UDI-DI
008416831468R-1FG
FDA Product Code
NJT
EMDN Code
W01030709 Primary antisera for immunohistology
GMDN Term
Claudin protein IVD, antibody
Device Class
Class C EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
04061841853732
GUDID
00841683151623
Device ClassEUDAMED
Class C
GUDID
Class I

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No