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Diagnostic BioSystems KA50

by Diagnostic BioSystems

Ref KA-50Model Detection Systems

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 Number08464050KA50F9Q Basic UDI-DI 00846405014231UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846405014231 UDI-DI Date5 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  • Withdrawn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
Universal Alkaline Phosphatase Immunostaining Kit (For Mouse and Rabbit Primary Antibodies) EUDAMED
Diagnostic BioSystems GUDID
Generic Name
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Model / Reference
Detection Systems EUDAMED
KA-50 EUDAMED
KA50 GUDID
Description
Alkaline Phosphatase Mouse and Rabbit Staining Kit ,100 Tests
Primary DI / UDI-DI
00846405014231
Basic UDI-DI
08464050KA50F9Q
FDA Product Code
NJT
EMDN Code
W01030711 Immunohistology kits
GMDN Term
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Detection Systems
KA-50
GUDID
KA50
Device ClassEUDAMED
Class A
GUDID
Class I

Other devices from Diagnostic BioSystems

See all devices from Diagnostic BioSystems →

Properties

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

Other properties (18)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No