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Tissue-Tek® Genie® 8254-C010

by Sakura Finetek USA, Inc

Ref 8254-C010

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

CE IVDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-00615233009067 Basic UDI-DI 00615233009067UDI-DIDate24 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00615233009067 UDI-DI Date14 Aug 2020ListedStatusListed 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  • Withdrawn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/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Tissue-Tek Genie® anti-TIA-1 Mouse Monoclonal Antibody [2G9A10F5] EUDAMED
Tissue-Tek® Genie® GUDID
Generic Name
Human T-cell lymphotrophic virus 1 (HTLV1) antibody IVD, reagent
Model / Ref / Catalog
8254-C010
Primary DI / UDI-DI
00615233009067
Basic UDI-DI
B-00615233009067
FDA Product Code
NJT
EMDN Code
W0102039099 Tumour markers - other
GMDN Term
Human T-cell lymphotrophic virus 1 (HTLV1) antibody IVD, reagent
Device Class
Class IVD General EUDAMED
Class I GUDID
Regulation Number
864.1860
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
GUDID
Class I

Related devices

Category: Human T-cell lymphotrophic virus 1 (HTLV1) antibody IVD, reagent

Other devices from Sakura Finetek USA, Inc

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Properties

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

Other properties (15)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No