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VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)

by Biomerieux, Inc.

510(k) K161217

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 NumberK161217 Date12 Jan 2017ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1464-2024 FDA Class I initiated 14 Mar 2024

    Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result of MIC=0.5, 1, 2.

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  • Withdrawn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, 1 Oct 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 Negative Ceftriaxone is an automated antimicrobial susceptibility test system used to determine the effectiveness of Ceftriaxone against Gram-negative bacteria. The test contains Ceftriaxone concentrations of 0.12, 0.25, 1, 4 and 16 µg/mL with a reporting range of ≤ 0.25 - ≥64 µg/mL.

This device is manufactured by bioMerieux, Inc. and is classified as a Class II medical device under product code LON. It is supplied as a component of the VITEK 2 AST-Gram Negative card and is intended for use in microbiology laboratories. The device received FDA 510(k) clearance with K161217 on January 12, 2017.

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