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Genemed® 10-0056

by Sakura Finetek USA, Inc

Genemed® 10-0056 is a Class I device made by Sakura Finetek USA, Inc, listed in FDA GUDID since 28 Dec 2019 (UDI-DI 00615233006899), registry data as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00615233006899 UDI-DI Date28 Dec 2019ListedStatusListed 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  • Withdrawn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
Genemed®
Generic name
Immunohistochemistry endogenous enzyme blocking reagent IVD
Model / Ref / Catalog
10-0056
Primary DI / UDI-DI
00615233006899
FDA product code
PPM
GMDN term
Immunohistochemistry endogenous enzyme blocking reagent IVD
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: Immunohistochemistry endogenous enzyme blocking reagent IVD

Similar devices

Other devices filed under FDA product code PPM (General purpose reagent).

Other devices from Sakura Finetek USA, Inc

See all devices from Sakura Finetek USA, Inc →

Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)