Sep 18 2009 - The Focus Diagnostics Influenza A H1N1 (2009) Real Time RT-PCR is intended for use in CLIA High Complexity Laboratories with the ability to perform RT-PCR using the Roche MagNA Pure™ LC and the AB 7500 Real Time PCR System for the in vitro qualitative detection of 2009 H1N1 influenza viral RNA in nasopharyngeal swabs (NPS), nasal swabs (NS), throat swabs (TS), and nasal aspirates (NA) from human patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors.
This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization. This test is only authorized for the duration of the declaration of emergency under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1). The declaration of emergency will expire on April 26, 2010, unless it is terminated or revoked sooner or renewed.