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FITC-labelled anti-human IgA with Evans Blue AF 601-0540-R

by EUROIMMUN Medizinische Labordiagnostika AG

Ref AF 601-0540-RModel AF 601-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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4049016AF601R98 Basic UDI-DI 04049016151302UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04049016151302 UDI-DI Date4 Mar 2026ListedStatusListed 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  • Withdrawn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

Trade Name
FITC-labelled anti-human IgA with Evans Blue
Generic Name
Human immunoglobulin A (IgA) animal conjugate antibody reagent IVD
Model / Reference
AF 601-0540-R, AF 601-R
Primary DI / UDI-DI
04049016151302
Basic UDI-DI
4049016AF601R98
FDA Product Code
PPM
EMDN Code
W05039080 Devices for samples analyses - other accessories
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

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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