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.
Source: Response Biomedical Corp. View latest company information
Posted: April 22, 2008
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