ETEST Fosfomycin (FO) (0.032-512 µg/mL)

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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

Trade Name

ETEST® Fosfomycin (FO)

Generic Name

Antibacterial minimum inhibitory concentration (MIC) IVD

Model / Reference

542890 EUDAMED

542594 EUDAMED

ETEST® Fosfomycin (FO) GUDID

Primary DI / UDI-DI

03573026619435, 03573026622275

Basic UDI-DI

357302BUDI002017T9, 357302BUDI000848UE

Unit of Use DI

03573026622565

510(k) Number

K210757 ↗

FDA Product Code

JWY

EMDN Code

W0104080501 Mic systems - dilution methods (incl. e-test)

GMDN Term

Antibacterial minimum inhibitory concentration (MIC) IVD

Device Class

Class B EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 866.1640

EU market of registration

France

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

  Class II

  CE/IVDR FDA 510(k) K192738 Active Cleared 26 Nov 2019 +1authorizations

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  Class II

  CE/IVDR FDA 510(k) K250274 Active Cleared 30 Apr 2025

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  Class II

  CE/IVDR FDA 510(k) K183031 Active Cleared 11 Jan 2019

• Etest Ceftaroline (0.002 - 32ug/ml)

  Class II

  FDA 510(k) K151873 Active Cleared 7 Oct 2015

• ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)

  Class II

  CE/IVDR FDA 510(k) K190154 Active Cleared 1 May 2019

• Vidas C Difficile Gdh

  Class I

  FDA 510(k) K132010 Active Cleared 9 Oct 2013

See all devices from Biomerieux S.A. →

• What is the ETEST Fosfomycin (FO) used for in a clinical lab setting?

  The ETEST Fosfomycin (FO) is a manual antimicrobial susceptibility test system designed to determine the minimum inhibitory concentration (MIC) of fosfomycin against bacterial isolates. This helps clinicians assess how susceptible specific bacteria are to fosfomycin treatment, guiding appropriate antibiotic therapy decisions.

• How is the ETEST Fosfomycin (FO) strip supplied, and is it reusable?

  The ETEST Fosfomycin (FO) is supplied as a ready-to-use strip for microbiological testing, meaning no additional preparation is required before use. It is explicitly intended for single-use only, so each strip should not be reused after a single test.

• What storage conditions are required for the ETEST Fosfomycin (FO) strips?

  The device must be stored under controlled temperatures to maintain its integrity and performance. While the exact temperature range isn’t specified in the data, proper storage is critical for preserving the accuracy of the MIC results, so always follow the manufacturer’s instructions for optimal conditions.

• What regulatory pathways does the ETEST Fosfomycin (FO) follow, and what does that mean for its use?

  The ETEST Fosfomycin (FO) has received FDA 510(k) clearance and complies with the In Vitro Diagnostic Regulation (IVDR). This means it has undergone regulatory review to ensure its safety, performance, and conformity with standards for antimicrobial susceptibility testing, allowing its use in clinical laboratories under these approved frameworks.

• Are there different sizes or models of the ETEST Fosfomycin (FO) strip, and what MIC range does it cover?

  The ETEST Fosfomycin (FO) is available in a single format with a MIC range of 0.032 to 512 µg/mL, covering a broad spectrum for testing bacterial susceptibility. There are no variations in strip sizes or models listed in the data, so this is the standard offering for fosfomycin testing.