FDA clears Quidel's pregnancy test
This article was originally published in Clinica
Executive Summary
Quidel's RapidVue hCG pregnancy test has received 510(k) clearance from the US FDA. The lateral flow immunoassay detects human chorionic gonadotropin (hCG), a hormone that is produced during pregnancy. The test is performed on a urine sample and produces results in three minutes.