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Etest Cefotaxime

by Ab Biodisk Sweden 510(k)

510(k) K981137

Product code JWY

Overview

Etest Cefotaxime is a quantitative technique for determining the susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination. The device is used for MIC determination of Cefotaxime in the range of 0.016 - 256 µg/ml or 0.002 - 32 µg/ml with non-fastidious Gram positive and Gram negative aerobic bacteria.

The Etest Cefotaxime is supplied as a test strip and is used in microbiology laboratories. It is intended for single-use and is not MRI safe. The device is authorized under FDA 510K clearance with product code JWY and is classified as a Manual Antimicrobial Susceptibility Test System. It is manufactured by Ab Biodisk and has the model number K981137.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK981137 Date9 Jun 1998ClearedStatusActive

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
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1947-2015 FDA Class II initiated 12 Jun 2015

    QC results were out of range resulting in false resistant strains.

Specification

510(k) · synced 6 Oct 2026

510(k) Number
FDA Product Code
JWY
Device Class
Class II
Regulation
21 CFR Part 866.1640
Advisory Committee
Microbiology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Etest Cefotaxime used for?

    The Etest Cefotaxime is a quantitative technique used in microbiology laboratories to determine the susceptibility of clinically significant bacteria to Cefotaxime, providing a gradient of 15 doubling dilutions for MIC determination.

  • How is the Etest Cefotaxime supplied and can it be reused?

    The Etest Cefotaxime is supplied as a test strip and is intended for single-use only. It should not be reused as it is designed for one-time testing to ensure accurate results.

  • What is the measurement range of the Etest Cefotaxime?

    The Etest Cefotaxime provides MIC determination in the range of 0.016 - 256 µg/ml or 0.002 - 32 µg/ml when used with non-fastidious Gram positive and Gram negative aerobic bacteria.

  • What is the regulatory status of the Etest Cefotaxime?

    The Etest Cefotaxime is authorized under FDA 510K clearance with product code JWY and is classified as a Manual Antimicrobial Susceptibility Test System, manufactured by Ab Biodisk with model number K981137.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K981137 24 fields · synced 6 Oct 2026