Quidel, a US-based virology assays and molecular diagnostic systems provider, has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer. It is used ...
Tags: FDA Clearance, HCG Fluorescent
Quidel has won FDA 510(k) clearance for its Sofia hCG fluorescent immunoassay (FIA) for use on the Sofia Analyzer to detect elevated levels of human chorionic gonadotropin (hCG), an early indicator of pregnancy. The Sofia Analyzer and ...
Tags: Quidel, Fluorescent Immunoassay