FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

175,218 clearances · 1976 to present · Updated monthly from FDA records

253 results for "bioMerieux, Inc."

25–48 of 253

Search insights Median review: 59d Cleared: 100% Top manufacturer: bioMerieux, Inc. Lead specialty: Microbiology

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Cleared Sep 14, 2021

VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)

VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)

VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)

VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)

VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)

VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL)

VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL)

VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL)

VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL)

BACT/ALERT MP Reagent System

VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)

VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL)

VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL)

VITEK 2 AST-Gram Negative Imipenem (= 16 ug/mL)

VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance

VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL)

VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL

VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)

Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL)

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