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."

49–72 of 253

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

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Cleared Jun 21, 2017

VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL)

Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)

BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO

VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL)

VIDAS B.R.A.H.M.S. PCT (PCT)

VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL)

VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)

VITEK 2 AST-GN Tobramycin (/= 16 ug/mL)

chromID Strepto B agar

VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL)

VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL)

VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL)

VIDAS B.R.A.H.M.S. PCT (PCT)

VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL)

VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL)

VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL

VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE

VITEK 2 AST - YEAST FLUCONAZOLE

VITEK 2 AST GP CEFTAROLINE

VITEK 2 AST ST MEROPENEM

VITEK 2 AST-ST TIGECYCLINE

VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN

K132573 · LON

bioMerieux, Inc.

Microbiology · 28d

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