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Article: Response Biomedical Obtains Special 510k U.S. FDA Clearance to Add Analytical Reactivity Information for the 2009 H1N1 Influenza a Virus to the RAMP[R] Influenza A/B Assay Package Insert.
- Article from:
- Blood Weekly
- Article date:
- November 5, 2009
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Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) announced that the Company has been granted a Special 510(k) U.S. FDA clearance for an update to the Company's RAMP[R] Influenza A/B Assay Package Insert to include analytical reactivity information for a strain of the 2009 H1N1 virus cultured from positive respiratory specimens. The RAMP[R] Influenza A/B Assay is marketed in the United States by 3M Health Care as the 3M™ Rapid Detection Flu A+B Test and is used to identify influenza A and B in human specimens (see also Response Biomedical Corporation).
Although the RAMP[R] Influenza A/B Assay has been shown to detect the 2009 influenza A (H1N1) virus ...