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Anti-Glutamate receptor (type NMDA) IFA FB 112d-1005-51

by EUROIMMUN Medizinische Labordiagnostika AG

Ref FB 112d-1005-51Model FB 112d-51

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

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

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-04049016092599 Basic UDI-DI 04049016092599UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049016092599 UDI-DI Date19 Dec 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Anti-Glutamate receptor (type NMDA) IIFT EUDAMED
Anti-Glutamate receptor (type NMDA) IFA GUDID
Generic Name
N-methyl-D-aspartate (NMDA) receptor antibody IVD, kit, fluorescent immunoassay
Model / Reference
FB 112d-1005-51, FB 112d-51
Primary DI / UDI-DI
04049016092599
Basic UDI-DI
B-04049016092599
510(k) Number
FDA Product Code
OSK
EMDN Code
W0102100299 Neuro-auto-immune disease - other
GMDN Term
N-methyl-D-aspartate (NMDA) receptor antibody IVD, kit, fluorescent immunoassay
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
866.5660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Related devices

Cleared under the same submission (K100017)

Other devices from EUROIMMUN Medizinische Labordiagnostika AG

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Properties

  • Single Use
  • Human Tissues
  • Professional Testing
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

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