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Diagnostic BioSystems HL72K

by Diagnostic BioSystems

Ref HL72KModel 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 Number08464050HL72KBW Basic UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00846405019274 UDI-DIDate8 Jun 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No notified-body 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  • Withdrawn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
HighLighter Core Kit EUDAMED
Diagnostic BioSystems GUDID
Generic Name
Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry
Model / Reference
HL72K, Detection Systems
Primary DI / UDI-DI
00846405019274
Basic UDI-DI
08464050HL72KBW
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
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