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N/A K36

by Hardy Diagnostics GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00819398021418 UDI-DIDate1 Jun 2020ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Specification

GUDID

Trade Name
N/A
Generic Name
Differential/selective broth culture medium IVD
Model / Ref / Catalog
K36
Description
Malonate Broth, 5mL, 15x103mm tube, 20 tubes/pack For the differentiation of gram negative bacilli based on malonate utilization.
Primary DI / UDI-DI
00819398021418
FDA Product Code
JSH
GMDN Term
Differential/selective broth culture medium IVD
Regulation Number
866.2320
Commercial Distribution
In Commercial Distribution

Related devices

Category: Differential/selective broth culture medium IVD

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