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FITC-labelled anti-human IgA

by EUROIMMUN Medizinische Labordiagnostika AG 2 variants

Ref AF 101-0546-RModel AF 101-R

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

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 Number4049016AF101R85 Basic UDI-DI 04049016151593UDI-DIDate20 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049016151593 UDI-DI Date8 Nov 2024ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

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  • Withdrawn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

Generic Name
Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD
Model / Reference
AF 101-R, AF 101-0546-R
Primary DI / UDI-DI
04049016151593
Basic UDI-DI
4049016AF101R85
FDA Product Code
PPM
EMDN Code
W01029099 Immunochemistry reagents - other
GMDN Term
Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.4010
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
DE-MF-000005296

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Properties

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

Other properties (16)

  • Sterile: 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