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Genemed® 10-0028

by Sakura Finetek USA, Inc

Genemed 10-0028 is a pH-adjusted buffer solution IVD (FDA Class I; FDA product code PPM, General purpose reagent) made by Sakura Finetek USA, Inc, listed in FDA GUDID since 28 Dec 2019 (UDI-DI 00615233007018), 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 Number00615233007018 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  • Withdrawn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
pH-adjusted buffer solution IVD
Model / Ref / Catalog
10-0028
Primary DI / UDI-DI
00615233007018
FDA product code
PPM
GMDN term
pH-adjusted buffer solution IVD
Device class
Class I
Regulation number
864.4010
GUDID distribution status
In Commercial Distribution

Related devices

Category: pH-adjusted buffer solution IVD

Similar devices in this category

Other devices filed under pH-adjusted buffer solution IVD.

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Properties

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