
Osmetech Molecular Diagnostics
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ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING is an FDA 510(k)-cleared medical device (K093974) manufactured by Osmetech Molecular Diagnostics. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 21, 2010. Regulation: 8.