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

Cleared Apr 30, 2025

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

K250274 · JWY

Microbiology · 90d

Cleared Nov 12, 2021

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

K210757 · JWY

Microbiology · 242d

Cleared Nov 26, 2019

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

K192738 · JWY

Microbiology · 60d

Cleared Sep 27, 2019

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

K192050 · JWY

Microbiology · 58d

Cleared Aug 22, 2019

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

K191953 · JWY

Microbiology · 31d

Cleared May 01, 2019

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

K190154 · JWY

Microbiology · 91d

Cleared Jan 11, 2019

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

K183031 · JWY

Microbiology · 71d

Cleared Jul 06, 2018

CHROMID CARBA agar (CARB)

K181092 · JSO

Microbiology · 72d

Cleared Jul 03, 2018

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

K180936 · JWY

Microbiology · 84d

Cleared Apr 27, 2017

RAPIDEC CARBA NP

K162385 · PTJ

Microbiology · 245d

Cleared Oct 07, 2015

Etest Ceftaroline (0.002 - 32ug/ml)

K151873 · JWY

Microbiology · 90d

Cleared Oct 09, 2013

VIDAS C DIFFICILE GDH

K132010 · MCB

Microbiology · 100d

Cleared Jun 04, 2013

VIDAS LYME IGM

K122979 · LSR

Microbiology · 251d

Cleared Mar 05, 2013

VIDAS LYME IGG

K122986 · LSR

Microbiology · 160d

Cleared May 16, 2011

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

K102535 · JWY

Microbiology · 255d