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BIOMERIEUX

5 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) (K260281)BIOMERIEUX2026-03-26
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856)Biomérieux2025-06-12
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD (K232395)Biomérieux2023-10-05
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)BIOMERIEUX2015-07-09
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML (K102668)BIOMERIEUX2010-11-17

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