Quidel Corporation
QDEL, a provider of rapid diagnostic testing solutions,
cell-based virology assays and molecular diagnostic systems,
announced today that it has received 510(k) clearance from the United
States Food and Drug Administration (FDA) for its Sofia(R) hCG
fluorescent immunoassay for use on the Sofia Analyzer for the rapid,
objective detection of elevated levels of human chorionic
gonadotropin (hCG), an early indicator of pregnancy.
Sofia is the brand name for Quidel's next-generation, immunoassay
system. The Sofia Analyzer and Sofia hCG FIA with proprietary Kinetic
Check(TM) Technology combine unique immunofluorescence chemistry,
advanced lateral flow technology, and failure alert and fail-safe
systems designed to ensure a reliable, objective, highly accurate,
diagnostic result within three (3) minutes of application of the
patient's specimen.
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