Biomerieux S.A. - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
Biomerieux S.A. has 16 FDA 510(k) cleared microbiology devices. Based in Craponne, FR.
Latest FDA clearance: Apr 2025. Active since 2011.
Browse the complete list of FDA 510(k) cleared microbiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) cleared devices by Biomerieux S.A.
16 devices
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
Jun 08, 2015
VIDAS FT4
Chemistry
705d