Quidel gets FDA clearance for Sofia hCG fluorescent immunoassay

theflyonthewall.com

Quidel Corporation announced that it has received 510(k) clearance from the United States Food and Drug Administration for its Sofia hCG fluorescent immunoassay for use on the Sofia Analyzer for the detection of elevated levels of human chorionic gonadotropin, an early indicator of pregnancy. The 510(k) clearance allows Quidel to market and sell its new Sofia hCG FIA in the United States.

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