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

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

510(k) Number

K183031 ↗

FDA Product Code

JWY

Device Class

Class II

Regulation

21 CFR Part 866.1640

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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

  Class II

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

• 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 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 clinical application does the ETEST Meropenem/Vaborbactam (MEV) test strip support in microbiology labs?

  The ETEST Meropenem/Vaborbactam (MEV) test strip is designed to determine bacterial susceptibility to the combination of meropenem and vaborbactam. It provides quantitative minimum inhibitory concentration (MIC) results, which help clinicians assess whether bacterial isolates are likely to respond to treatment with this antibiotic pairing. This is particularly useful for guiding infection management decisions in microbiology laboratories.

• How is the ETEST Meropenem/Vaborbactam (MEV) test strip supplied, and is it reusable?

  The ETEST Meropenem/Vaborbactam (MEV) is supplied as a single-use test strip, meaning each strip is intended for one test only. This ensures accuracy and sterility for each measurement, reducing the risk of cross-contamination or degradation of results. Discard the strip after use and replace it with a new one for subsequent tests.

• What storage requirements apply to the ETEST Meropenem/Vaborbactam (MEV) strips, and do they need special handling?

  The test strips do not require special storage conditions beyond those outlined in the manufacturer’s instructions. They should be stored in a dry environment, protected from direct sunlight and extreme temperatures. Avoid freezing or exposing them to moisture, as this could compromise their performance. Always refer to the included packaging for precise storage guidelines.

• What regulatory pathways does the ETEST Meropenem/Vaborbactam (MEV) follow, and how does this affect its use?

  The ETEST Meropenem/Vaborbactam (MEV) is regulated under the FDA’s 510(k) pathway and complies with the In Vitro Diagnostic Regulation (IVDR). This means it has undergone rigorous evaluation to ensure its safety, performance, and clinical utility for antimicrobial susceptibility testing. Laboratories using this device can rely on its adherence to stringent regulatory standards, though compliance with local laboratory protocols and guidelines remains essential for accurate results.