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Tissue-Tek® Genie® 8254-M250

by Sakura Finetek USA, Inc

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00615233009074 UDI-DI Date14 Aug 2020ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Tissue-Tek® Genie®
Generic Name
Human T-cell lymphotrophic virus 1 (HTLV1) antibody IVD, reagent
Model / Ref / Catalog
8254-M250
Primary DI / UDI-DI
00615233009074
FDA Product Code
NJT
GMDN Term
Human T-cell lymphotrophic virus 1 (HTLV1) antibody IVD, reagent
Device Class
Class I
Regulation Number
864.1860
GUDID distribution status
In Commercial Distribution

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

  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No