Biomerieux S.A.
Biomerieux S.A. holds FDA 510(k) medical device clearances, first cleared 2011, most recent 2025.
Top product codes for Biomerieux S.A.
Recent clearances by Biomerieux S.A.
- K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)
- K210757 — ETEST Fosfomycin (FO) (0.032-512 µg/mL)
- K192738 — ETEST Delafloxacin (DFX) (0.002-32 µg/mL)
- K192050 — ETEST Eravacycline (ERV) (0.002 32 µg/mL)
- K191953 — ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)
- K190154 — ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL)
- K183031 — ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
- K181092 — CHROMID CARBA agar (CARB)
- K180936 — ETEST Telavancin (TLA) (0.002-32 ug/mL)
- K162385 — RAPIDEC CARBA NP
- K151873 — Etest Ceftaroline (0.002 - 32ug/ml)
- K132058 — VIDAS FT4
- K132010 — VIDAS C DIFFICILE GDH
- K122979 — VIDAS LYME IGM
- K122986 — VIDAS LYME IGG
- K102535 — ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
Data sourced from openFDA. This site is unofficial and independent of the FDA.