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Diagnostic BioSystems K038-500AN

by Diagnostic BioSystems

Ref K038-500ANModel Antigen Retrieval Buffers

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number08464050K038500ANP6 Basic UDI-DI 00846405016709UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846405016709 UDI-DI Date8 Jun 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  • Withdrawn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
Montage EDTA Antigen Retrieval Solution EUDAMED
Diagnostic BioSystems GUDID
Generic Name
pH-adjusted buffer solution IVD
Model / Reference
K038-500AN, Antigen Retrieval Buffers
Primary DI / UDI-DI
00846405016709
Basic UDI-DI
08464050K038500ANP6
FDA Product Code
JCC
EMDN Code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
GMDN Term
pH-adjusted buffer solution IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.4010
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Other devices from Diagnostic BioSystems

See all devices from Diagnostic BioSystems →

Properties

  • Single Use
  • Reagent
  • Professional Testing
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal 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
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No