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Etest® IMIPENEM

by Biomerieux, Inc.

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03573026548933 UDI-DI Date18 Nov 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0825-2023 FDA Class II initiated 9 Nov 2022

    As the temperature and time out of range was exceeded, product performances cannot be guaranteed

    • Terminated Z-1529-2017 FDA Class II initiated 15 Dec 2016

    Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Antibacterial minimum inhibitory concentration (MIC) IVD
Model / Reference
Etest® IMIPENEM
Primary DI / UDI-DI
03573026548933
510(k) Number
FDA Product Code
JWY
GMDN Term
Antibacterial minimum inhibitory concentration (MIC) IVD
Device Class
Class II
Regulation Number
866.1640
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K960989)

Other devices from Biomerieux, Inc.

See all devices from Biomerieux, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No