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Na R01622

by Remel, Inc. United States GUDID

Product code JTZ

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848838002458 UDI-DIDate24 Sep 2016ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

2 recalls · FDA

    • Terminated Z-2137-2018 FDA Class II initiated 4 May 2018

    Product may fail performance testing for S aureus ATCC 43300.

    • Terminated Z-0644-2010 FDA Unclassified (pre-2012) initiated 8 Dec 2009

    The product may fail to adequately grow methicillin resistant Staphylococcus aureus ATCC 43300 and Staphylococcus aureus ATCC 33591.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Na
Generic Name
Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood
Model / Reference
R01622
Primary DI / UDI-DI
00848838002458
510(k) Number
FDA Product Code
JTZ
GMDN Term
Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood
Device Class
Class II
Regulation Number
866.1700
Commercial Distribution
In Commercial Distribution

Related devices

Category: Mueller-Hinton agar antimicrobial susceptibility culture medium IVD, sheep blood

Cleared under the same submission (K850291)

Other devices from Remel, Inc.

See all devices from Remel, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Lot / Batch Number
  • Expiration Date
Other properties (12)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 6da51b8f-3268-4529-9206-cd60c2fdf140 34 fields · synced 23 Oct 2026