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Super Sensitive Wash Buffer HK583-5K

by Biogenex Laboratories, Inc.

Super Sensitive Wash Buffer HK583-5K is a pH-adjusted buffer solution IVD (FDA Class I; FDA product code NJT, Immunohistochemistry Reagents And Kits) made by Biogenex Laboratories, Inc., listed in FDA GUDID since 29 Mar 2023 (UDI-DI 00810119673282), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810119673282 UDI-DI Date29 Mar 2023ListedStatusListed 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  • Withdrawn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
Super Sensitive Wash Buffer
Generic name
pH-adjusted buffer solution IVD
Model / Ref / Catalog
HK583-5K
Primary DI / UDI-DI
00810119673282
FDA product code
NJT
GMDN term
pH-adjusted buffer solution IVD
Device class
Class I
Regulation number
864.1860
GUDID distribution status
In Commercial Distribution

Related devices

Category: pH-adjusted buffer solution IVD

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Other devices filed under pH-adjusted buffer solution IVD.

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Properties

  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)