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Biomerieux S.A. FDA Approvals
0 new drug approvals and 2 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 |
|---|
| ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)510(k)Apr 30, 2025Microbiology |
| ETEST Fosfomycin (FO) (0.032-512 µg/mL)510(k)Nov 12, 2021Microbiology |