bioMerieux, Inc. - FDA 510(k) Cleared Devices

Cleared Aug 21, 2025

VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)

K251579 · LON

Microbiology · 90d

Cleared Mar 14, 2025

VITEK COMPACT PRO

K234012 · LON

Microbiology · 451d

Cleared Jun 12, 2024

VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)

K232967 · NGZ

Microbiology · 265d

Cleared Jun 07, 2024

VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

K232963 · NGZ

Microbiology · 260d

Cleared Mar 11, 2024

VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)

K234000 · LON

Microbiology · 84d

Cleared Oct 23, 2023

VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2...

K232201 · LON

Microbiology · 90d

Cleared Jul 05, 2023

VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP...

K230864 · LON

Microbiology · 98d

Cleared Jun 26, 2023

VITEK 2 AST-Gram Negative Levofloxacin (/=8 ug/mL)

K222378 · LON

Microbiology · 325d

Cleared Feb 16, 2023

VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL)

K223478 · LON

Microbiology · 90d

Cleared Feb 09, 2023

VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

K222073 · LON

Microbiology · 210d

Cleared Feb 03, 2023

VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)

K223481 · LON

Microbiology · 77d

Cleared Jan 27, 2023

VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP...

K220803 · LON

Microbiology · 315d