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Na CP114-10

by Remel, Inc. United States GUDID

Product code JTZ

Regulatory status

as of 24 Oct 2026

Recall ongoing on a related submission. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848838018855 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 America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1947-2025 FDA Class II initiated 1 May 2025 via K111429, on the same 510(k)

    Product may have an off color affecting perfomance

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Na
Generic Name
Mueller-Hinton broth antimicrobial susceptibility culture medium IVD
Model / Reference
CP114-10
Primary DI / UDI-DI
00848838018855
FDA Product Code
JTZ
GMDN Term
Mueller-Hinton broth antimicrobial susceptibility culture medium IVD
Device Class
Class II
Regulation Number
866.1700
Commercial Distribution
In Commercial Distribution

Related devices

Category: Mueller-Hinton broth antimicrobial susceptibility culture medium IVD

Cleared under the same submission (K111429)

Show all (12)

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 505e537f-a69b-4f14-861b-708f0963e471 33 fields · synced 23 Oct 2026