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Biomerieux S.A.

16 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (K250274)Biomerieux S.A.2025-04-30
ETEST Fosfomycin (FO) (0.032-512 µg/mL) (K210757)Biomerieux S.A.2021-11-12
ETEST Delafloxacin (DFX) (0.002-32 µg/mL) (K192738)Biomerieux S.A.2019-11-26
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) (K192050)Biomerieux S.A.2019-09-27
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) (K191953)Biomerieux S.A.2019-08-22
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) (K190154)Biomerieux S.A.2019-05-01
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) (K183031)Biomerieux S.A.2019-01-11
CHROMID CARBA agar (CARB) (K181092)Biomerieux S.A.2018-07-06
ETEST Telavancin (TLA) (0.002-32 ug/mL) (K180936)Biomerieux S.A.2018-07-03
RAPIDEC CARBA NP (K162385)Biomerieux S.A.2017-04-27
Etest Ceftaroline (0.002 - 32ug/ml) (K151873)Biomerieux S.A.2015-10-07
VIDAS FT4 (K132058)Biomerieux S.A.2015-06-08
VIDAS C DIFFICILE GDH (K132010)Biomerieux S.A.2013-10-09
VIDAS LYME IGM (K122979)Biomerieux S.A.2013-06-04
VIDAS LYME IGG (K122986)Biomerieux S.A.2013-03-05
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML (K102535)Biomerieux S.A.2011-05-16

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