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Vitek 2 Gram Positive Ertapenem

by Biomerieux, Inc.

510(k) K050076

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

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 NumberK050076 Date18 Feb 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

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  • Withdrawn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, 28 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 Gram Positive Ertapenem is an automated antimicrobial susceptibility test card designed for use with the VITEK 2 system in clinical laboratories. It is an in vitro test used to determine the susceptibility of Staphylococcus spp., Enterococcus spp. and S. agalactiae to antimicrobial agents.

The device is supplied as a single-use card and is intended for laboratory use only. It is classified as a Class II medical device and has received FDA 510(k) clearance with the product code LON. The device is not MRI compatible and should be stored according to the manufacturer's instructions.

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Questions

AI-generated answers, 28 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 Gram Positive Ertapenem used for?

    The VITEK 2 Gram Positive Ertapenem is an in vitro test card designed to determine the susceptibility of Staphylococcus spp., Enterococcus spp. and S. agalactiae to antimicrobial agents when used with the VITEK 2 system in clinical laboratories.

  • How is the VITEK 2 Gram Positive Ertapenem supplied?

    The device is supplied as a single-use card intended for laboratory use only. It should be stored according to the manufacturer's instructions and is not MRI compatible.

  • What is the regulatory classification of this device?

    The VITEK 2 Gram Positive Ertapenem is classified as a Class II medical device and has received FDA 510(k) clearance with the product code LON. It is not MRI compatible and should be stored according to the manufacturer's instructions.

  • Can the VITEK 2 Gram Positive Ertapenem be reused?

    No, the VITEK 2 Gram Positive Ertapenem is supplied as a single-use card and is not intended for reuse. Each card should be used only once according to the manufacturer's instructions to ensure accurate test results.