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bioMerieux, Inc. FDA Approvals
0 new drug approvals and 28 device clearances on file. This applicant is not matched to a listed company.
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A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| VITEK REVEAL GN AST Assay and VITEK REVEAL AST System510(k)Jul 8, 2026Microbiology |
| VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance510(k)Apr 15, 2026Microbiology |
| VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)510(k)Aug 21, 2025Microbiology |
| VITEK COMPACT PRO510(k)Mar 14, 2025Microbiology |
| VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL)510(k)Jun 12, 2024Microbiology |
| VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)510(k)Jun 7, 2024Microbiology |
| VIDAS TBI (GFAP, UCH-L1)510(k)May 1, 2024Immunology |
| VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)510(k)Mar 11, 2024Microbiology |
| VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin510(k)Oct 23, 2023Microbiology |
| VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin510(k)Jul 5, 2023Microbiology |
| VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL)510(k)Jun 26, 2023Microbiology |
| VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin510(k)Feb 16, 2023Microbiology |
| VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)510(k)Feb 9, 2023Microbiology |
| VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL)510(k)Feb 3, 2023Microbiology |
| VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin510(k)Jan 27, 2023Microbiology |
| VITEK 2 AST-Gram Positive Cefoxitin Screen510(k)Oct 13, 2022Microbiology |
| VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL)510(k)Aug 8, 2022Microbiology |
| VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin510(k)Jul 12, 2022Microbiology |
| VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)510(k)Jun 3, 2022Microbiology |
| VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL)510(k)Apr 14, 2022Microbiology |
| VITEK MS PRIME510(k)Mar 15, 2022Microbiology |
| VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole510(k)Feb 25, 2022Microbiology |
| VITEK 2 AST-Gram Positive Linezolid (<=0.5 >=8 µg/mL)510(k)Feb 4, 2022Microbiology |
| VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL)510(k)Oct 28, 2021Microbiology |
| VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL)510(k)Sep 14, 2021Microbiology |
| VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL)510(k)Aug 30, 2021Microbiology |
| VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL)510(k)Jul 9, 2021Microbiology |
| VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML)510(k)Jun 14, 2021Microbiology |