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Ncl-L-CD163

by Leica Biosystems Newcastle Ltd

Ref NCL-L-CD163

Active European Union. Also listed in GUDID (US).

CE IVDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05055331323712 Basic UDI-DI 05055331323712UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055331323712 UDI-DI Date19 Mar 2021ListedStatusListed GUDID: 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  • Withdrawn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/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Ncl-L-CD163 EUDAMED
Novocastra™ GUDID
Generic Name
CD163 cell marker IVD, antibody
Device Name
Novocastra Liquid Mouse Monoclonal Antibody CD163
Model / Ref / Catalog
NCL-L-CD163, CD163-L-CE
Primary DI / UDI-DI
05055331323712
Basic UDI-DI
B-05055331323712
FDA Product Code
NJT
EMDN Code
W01030709 Primary antisera for immunohistology
GMDN Term
CD163 cell marker IVD, antibody
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NCL-L-CD163
GUDID
CD163-L-CE
Device ClassEUDAMED
Class IVD General
GUDID
Class I

Manufacturer details

EUDAMED SRN
GB-MF-000020595
Authorised representative
AR Experts B.V. NL-AR-000023989

Other devices from Leica Biosystems Newcastle, Limited

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Properties

  • Contains Latex
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

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