BIOMERIEUX - FDA 510(k) Cleared Devices
Recent clearances: VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL), 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, ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - BIOMERIEUX Microbiology ✕
3 devices
Cleared
Mar 26, 2026
VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)
Microbiology
56d
Cleared
Jul 09, 2015
VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M,...
Microbiology
434d
Cleared
Nov 17, 2010
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML
Microbiology
62d