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FDA Issues 7 Emergency Permits for H1N1 Kits

06/21/2010

Federal Register Notice: FDA has issued seven Emergency Use Authorizations, two of which were amended after initial issuance, for certain in vitro diagnostic devices. The authorizations follow the determination by the then acting secretary of the Department of Health and Human Services Charles E. Johnson that a public health emergency exists involving 2009 H1N1 Influenza A that affects, or has the significant potential to affect, national security. FDA issued the authorizations for ViraCor Laboratories’ ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test, Epoch BioSciences’ ELITech Molecular Diagnostics 2009-H1N1 Influenza A virus Real-Time RT-PCR test, Longhorn Vaccines and Diagnostics’ Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay, Diagnostic Hybrids, Inc.’s D\3\ Ultra 2009 H1N1 Influenza A Virus ID Kit, Qiagen’s artus Inf. A H1N1 2009 LC RT-PCR Kit, IntelligentMDX’s IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay, and IQuum, Inc.’s Liat Influenza A/2009 H1N1 Assay. To view this notice, click here.

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