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Alere Receives FDA Clearance for Alere i RSV Rapid Molecular Test

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Additional Relevant Details Alere i RSV test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the detection of RSV infection in children and adults. Following Alere i Influenza A & B and Alere i Strep A, Alere i RSV is the latest testing application on the Alere i platform and is the first molecular test that can be used at the point-of-care to detect RSV in 13 minutes or less. Alere will shortly submit an application for CLIA (Clinical Laboratory Improvement Amendments) waiver of the Alere i RSV test. Alere i testing applications have previously been CLIA-waived for Influenza A & B and Strep A.
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Occurred on:
Aug 19, 2016
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Related Keywords Rsv Rapid Molecular Test, Fda Clearance