ETEST Delafloxacin (DFX) (0.002-32 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® Delafloxacin (DFX)

Generic Name

Antibacterial minimum inhibitory concentration (MIC) IVD

Model / Reference

540252 EUDAMED

ETEST® Delafloxacin (DFX) GUDID

Primary DI / UDI-DI

03573026603205

Basic UDI-DI

357302BUDI000812TR

510(k) Number

K192738 ↗

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 Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

  Class II

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

• ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)

  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

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

  Class II

  CE/IVDR FDA 510(k) K210757 Active Cleared 12 Nov 2021 +1authorizations

See all devices from Biomerieux S.A. →

• What types of bacteria can the ETEST Delafloxacin be used to test for susceptibility to delafloxacin?

  The ETEST Delafloxacin (DFX) is designed for testing non-fastidious Gram-negative and Gram-positive aerobic bacteria, as well as fastidious bacteria. This makes it versatile for a broad range of clinical microbiology applications where bacterial susceptibility to delafloxacin may be relevant.

• Is the ETEST Delafloxacin system single-use, and how should the strips be stored?

  Yes, the ETEST Delafloxacin test strips are single-use only. To maintain accuracy and reliability, they must be stored under proper conditions as specified by the manufacturer. Incorrect storage could compromise the integrity of the test results.

• What regulatory pathways has the ETEST Delafloxacin undergone, and what does that mean for its use?

  The ETEST Delafloxacin has received FDA 510(k) clearance (K192738) under the Traditional pathway, demonstrating it is substantially equivalent to a predicate device. It has also obtained IVDR authorization, confirming compliance with European Union regulations for in vitro diagnostic medical devices. This means it can legally be used in clinical microbiology laboratories in the U.S. and EU under the specified regulatory frameworks.

• How is the ETEST Delafloxacin system supplied, and what is its primary use?

  The ETEST Delafloxacin is supplied as a reagent strip-based system, intended exclusively for manual antimicrobial susceptibility testing in clinical microbiology laboratories. It provides quantitative determination of bacterial susceptibility to delafloxacin, helping guide treatment decisions based on laboratory results.