Medical Device Manufacturer · FR , Craponne

Biomerieux S.A. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2011

Recent clearances: ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL), ETEST Fosfomycin (FO) (0.032-512 µg/mL), ETEST Delafloxacin (DFX) (0.002-32 µg/mL)

16

Total

16

Cleared

0

Denied

FDA 510(k) Regulatory Record - Biomerieux S.A. Microbiology ✕

15 devices

1-15 of 15

Cleared Apr 30, 2025

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

Microbiology · 90d

Cleared Nov 12, 2021

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

Microbiology · 242d

Cleared Nov 26, 2019

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

Microbiology · 60d

Cleared Sep 27, 2019

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

Microbiology · 58d

Cleared Aug 22, 2019

ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)

Microbiology · 31d

Cleared May 01, 2019

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

Microbiology · 91d

Cleared Jan 11, 2019

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

Microbiology · 71d

Cleared Jul 06, 2018

CHROMID CARBA agar (CARB)

Microbiology · 72d

Cleared Jul 03, 2018

ETEST Telavancin (TLA) (0.002-32 ug/mL)

Microbiology · 84d

Cleared Apr 27, 2017

RAPIDEC CARBA NP

Microbiology · 245d

Cleared Oct 07, 2015

Etest Ceftaroline (0.002 - 32ug/ml)

Microbiology · 90d

Cleared Oct 09, 2013

VIDAS C DIFFICILE GDH

Microbiology · 100d

Cleared Jun 04, 2013

Microbiology · 251d

Cleared Mar 05, 2013

Microbiology · 160d

Cleared May 16, 2011

ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML

Microbiology · 255d