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N/A L28

by Hardy Diagnostics GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00819398022194 UDI-DIDate3 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  • Withdrawn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
Enriched agar culture medium IVD
Model / Ref / Catalog
L28
Description
Loeffler's Slant, 5.5ml, 16x100mm tube, order by the package of 20 For the cultivation of Corynebacterium diphtheriae from clinical specimens.
Primary DI / UDI-DI
00819398022194
FDA Product Code
KZI
GMDN Term
Enriched agar culture medium IVD
Regulation Number
866.2330
Commercial Distribution
In Commercial Distribution

Related devices

Category: Enriched agar culture medium IVD

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