Response Biomedical Corp.’s (RPBIF.OB) Receives FDA Market Clearance for Rapid Respiratory Syncytial Virus Test
Response Biomedical Corporation announced this morning that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to market the company’s rapid Respiratory Syncytial Virus (RSV) test. The test runs on the RAMP(R) 200 Reader and will be marketed and sold by 3M Health Care as the 3M(TM) Rapid Detection RSV Test. The RSV Test is a qualitative immunochromatographic assay designed to be used as an in vitro diagnostic product with the 3M(TM) Rapid Detection Reader (manufactured by Response Biomedical) to detect the presence of RSV F-protein antigens in nasopharyngeal swab, nasopharyngeal aspirate, or nasal wash/aspirate specimens. Detecting RSV…