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Vitek 2 Esbl Test

by Biomerieux, Inc.

510(k) K040845

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040845 Date8 Jun 2004ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0837-2023 FDA Class II initiated 9 Nov 2022
    • Ongoing Z-0833-2023 FDA Class II initiated 9 Nov 2022

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
LON
Device class
Class II
Regulation
21 CFR Part 866.1645
Advisory committee
Microbiology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VITEK 2 ESBL Test is an automated microbiology system designed for the identification of ESBL-producing Enterobacteriaceae isolates. It is part of the VITEK 2 platform, which provides antimicrobial susceptibility testing and identification of microorganisms. The system utilizes miniaturized, closed cards to enhance lab safety and streamline workflow.

The VITEK 2 ESBL Test is supplied as part of an automated system and is intended for use in microbiology laboratories. It is a single-use test system that has received FDA 510(k) clearance as substantially equivalent. The device is regulated under product code LON and is classified as device class 2.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the VITEK 2 ESBL Test used for?

    The VITEK 2 ESBL Test is an automated microbiology system designed specifically for the identification of ESBL-producing Enterobacteriaceae isolates, helping laboratories detect antimicrobial resistance patterns efficiently.

  • How is the VITEK 2 ESBL Test supplied?

    The test is supplied as part of the VITEK 2 automated system platform, utilizing miniaturized, closed cards that enhance laboratory safety and streamline workflow processes in microbiology laboratories.

  • Is the VITEK 2 ESBL Test single-use or reusable?

    The VITEK 2 ESBL Test is a single-use test system, designed for one-time use to ensure accurate results and maintain sterility standards in laboratory testing environments.

  • What is the regulatory classification of the VITEK 2 ESBL Test?

    The device has received FDA 510(k) clearance as substantially equivalent, is regulated under product code LON, and is classified as device class 2 for antimicrobial susceptibility testing in microbiology laboratories.