Response Biomedical Receives FDA 510(k) Clearance of Rapid Influenza A+B Test

Response Biomedical Corporation has received FDA 510(k) clearance to market a rapid Influenza A+B test (Flu A+B test) and a new version of the RAMP® Reader, the RAMP® 200.

The test manufactured by Response Biomedical runs on the new RAMP® 200 Reader and will be marketed and sold worldwide exclusively by 3M Health Care as the 3M™ Rapid Detection Flu A+B Test. It is a qualitative immunochromatographic assay indicated for use as an in vitro diagnostic product with the 3M™ Rapid Detection Reader (manufactured by Response) to identify the presence of Flu A and Flu B nucleoprotein antigen in nasopharyngeal swab, nasopharyngeal aspirate, nasal wash/aspirate specimens.

Measurement of Flu A and Flu B aids in the rapid differential diagnosis of influenza viral infections through use of this test.

3M Health Care anticipates launching prior to the 2008-09 flu season in certain markets around the world.