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Na R01503

by Remel, Inc. United States GUDID

Product code JSO

Regulatory status

as of 24 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00848838001932 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

5 recalls · 3 ongoing · FDA

    • Ongoing Z-2038-2023 FDA Class II initiated 31 May 2023

    The test medium may not perform as intended.

  • 2 recalls, same reason

    • Ongoing Z-1424-2021 FDA Class II initiated 10 Mar 2021
    • Ongoing Z-1425-2021 FDA Class II initiated 10 Mar 2021

    When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.

  • 2 recalls, same reason

    • Terminated Z-2928-2011 FDA Unclassified (pre-2012) initiated 21 Apr 2011
    • Terminated Z-2929-2011 FDA Unclassified (pre-2012) initiated 21 Apr 2011

    Organism strains may fail to consistently produce confluent growth

Specification

GUDID · synced 23 Oct 2026

Trade Name
Na
Generic Name
Haemophilus species antimicrobial susceptibility culture medium IVD
Model / Reference
R01503
Primary DI / UDI-DI
00848838001932
510(k) Number
FDA Product Code
JSO
GMDN Term
Haemophilus species antimicrobial susceptibility culture medium IVD
Device Class
Class II
Regulation Number
866.1700
Commercial Distribution
In Commercial Distribution

Related devices

Category: Haemophilus species antimicrobial susceptibility culture medium IVD

Cleared under the same submission (K892928)

Similar devices

Also classified as Haemophilus species antimicrobial susceptibility culture medium IVD.

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 a3756816-07db-4ed9-8834-b93cac72ad70 34 fields · synced 23 Oct 2026