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Biomerieux FDA Approvals
0 new drug approvals and 3 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)510(k)Mar 26, 2026Microbiology |
| ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)510(k)Jun 12, 2025Microbiology |
| ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD510(k)Oct 5, 2023Microbiology |