ETEST Eravacycline (ERV) (0.002 – 32 µg/mL)

• • Ongoing Z-0851-2023 FDA Class II ·initiated 9 Nov 2022

  As the temperature and time out of range was exceeded, product performances cannot be guaranteed

510(k) Number

K192050 ↗

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 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

See all devices from Biomerieux S.A. →