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Tissue-Tek Genie® 8345-C010

by Sakura Finetek USA, Inc

Tissue-Tek Genie® 8345-C010 is a Class I device made by Sakura Finetek USA, Inc, listed in FDA GUDID since 23 Oct 2026 (UDI-DI 00615233010834), registry data as of 9 Nov 2026.

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

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00615233010834 UDI-DI Date23 Oct 2026ListedStatusListed GUDID: in commercial distribution

Official records

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  • Withdrawn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
Caldesmon protein IVD, antibody
Model / Ref / Catalog
8345-C010
Primary DI / UDI-DI
00615233010834
FDA product code
NJT
GMDN term
Caldesmon protein IVD, antibody
Device class
Class I
Regulation number
864.1860
GUDID distribution status
In Commercial Distribution

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)