Quidel, a provider of in-vitro rapid diagnostic testing solutions, has received US Food and Drug Administration (FDA) 510(k) clearance for the sale of Quidel’s RapidVue hCG test.
The 3-minute RapidVue hCG test is a lateral flow pregnancy immunoassay for the qualitative detection of human Chorionic Gonadotropin (hCG).
The test is Clinical Laboratory Improvement Amendments (CLIA)-waived for use with urine samples and no specimen manipulation is required to perform the test due to its dipstick format.
Quidel Corporation president and CEO Douglas Bryant said that their customers have expressed a preference for testing flexibility and our new RapidVue hCG product provides healthcare professionals with an additional format for pregnancy testing.
“RapidVue hCG is Quidel’s fourth product launch in the US this year and is further confirmation of our success at reinvigorating our new product pipeline,” Bryant said.