Quidel's RapidVue hCG lateral flow pregnancy immunoassay granted FDA 510(k) clearance

Quidel CorporationSep 2 2010

Quidel Corporation (NASDAQ: QDEL), a leading provider of rapid diagnostic testing solutions, announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for the sale of Quidel's RapidVue® hCG test, a lateral flow pregnancy immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG).

"Our customers have expressed a preference for testing flexibility and our new RapidVue hCG product provides healthcare professionals with an additional format for pregnancy testing," said Douglas Bryant, president and chief executive officer of Quidel Corporation. "RapidVue hCG is Quidel's fourth product launch in the United States this year and is further confirmation of our success at reinvigorating our new product pipeline."

The 3-minute RapidVue hCG test is CLIA-waived for use with urine samples. Due to the assay's dipstick format, RapidVue hCG requires no specimen manipulation in order to perform the test.