BIOMERIEUX
5 FDA 510(k) clearances · Manufacturer
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| Record | Firm | Date |
|---|---|---|
| VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (K260281) | BIOMERIEUX | 2026-03-26 |
| ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856) | Biomérieux | 2025-06-12 |
| ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD (K232395) | Biomérieux | 2023-10-05 |
| VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II (K141133) | BIOMERIEUX | 2015-07-09 |
| ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML (K102668) | BIOMERIEUX | 2010-11-17 |
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