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Ncl-L-Er-6F11

by Leica Biosystems Newcastle Ltd

Ref NCL-L-ER-6F11

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-05055331309617 Basic UDI-DI 05055331309617UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05055331309617 UDI-DI Date24 Sep 2016ListedStatusListed 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  • Withdrawn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-Er-6F11 EUDAMED
Novocastra™ GUDID
Generic Name
Estrogen (oestrogen)/progesterone receptor IVD, antibody
Device Name
Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra
Model / Ref / Catalog
NCL-L-ER-6F11, ER-6F11-L-F
Primary DI / UDI-DI
05055331309617 EUDAMED
05055331309600 GUDID
Basic UDI-DI
B-05055331309617
FDA Product Code
MYA
EMDN Code
W01030709 Primary antisera for immunohistology
GMDN Term
Estrogen (oestrogen)/progesterone receptor IVD, antibody
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
864.1860
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NCL-L-ER-6F11
GUDID
ER-6F11-L-F
Primary DI / UDI-DIEUDAMED
05055331309617
GUDID
05055331309600
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Manufacturer details

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

Other devices from Leica Biosystems Newcastle, Limited

See all devices from Leica Biosystems Newcastle, Limited →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • Combination Product
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No