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Latest Emergency Use Authorization Stories

2010-05-24 09:47:00

MADISON, N.J., and CYPRESS, Calif., May 24 /PRNewswire-FirstCall/ -- Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance to the Simplexa(TM) Influenza A H1N1 (2009) test on the 3M(TM) Integrated Cycler. The Simplexa test, developed and manufactured by Quest Diagnostics' Focus Diagnostics business, is the first to be cleared by...

2010-03-24 06:33:00

CAMBRIDGE, Mass., March 24 /PRNewswire/ -- IMDx announced today that its IMDx 2009 Influenza A H1N1 Real-Time RT-PCR Assay has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). The test, which is authorized for use on multiple instrument platforms (the Applied Biosystems 7500, the 7500 FAST Real-Time PCR Systems, and the 7500 Fast Dx Real-Time PCR Instrument) by CLIA High Complexity Laboratories to detect and differentiate 2009 Influenza A...

2010-02-23 08:15:00

SAN ANTONIO, Feb. 22 /PRNewswire/ -- Longhorn Vaccines & Diagnostics today announced it has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay(TM) in CLIA high complexity laboratories. . The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay(TM) is a ready-use assay that requires no mixing prior to use and has been authorized for use on the ABI 7500. The device includes PrimeStore MTM,...

2009-12-14 06:00:00

ST. GEORGE, Utah, Dec. 14 /PRNewswire/ -- DxNA announced today that the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its 2009 H1N1 influenza virus diagnostic test for use in DxNA's GeneSTAT(TM) detection platform. The new platform enables fast detection of the 2009 H1N1 influenza virus with a portable device weighing less than 10 pounds. In the United States, an Emergency Use Authorization (EUA) is a legal means for the FDA to...

2009-11-18 00:00:00

MADISON, N.J., Nov. 18 /PRNewswire-FirstCall/ -- Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the Simplexa Influenza A H1N1 (2009) test developed by its Focus Diagnostics business has been CE marked and is now available as a test kit for distribution to approximately 35 countries in Europe. Focus Diagnostics is showcasing the test at MEDICA 2009, November 18 to 21, 2009, at the Dusseldorf Fair...

2009-11-02 14:44:00

SILVER SPRING, Md., Nov. 2 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA). If granted, the EUA will allow the test to be used during the national...

2009-10-29 06:00:00

SAN DIEGO, Oct. 29 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) today announced that the US Food and Drug Administration (FDA) has granted an EUA (emergency use authorization) for its test, the Prodesse ProFlu-ST(TM), to be used in CLIA high complexity laboratories for the diagnosis of 2009 H1N1 influenza virus infection, aided by an algorithm that relies on seasonal influenza A/H1 virus and seasonal influenza A/H3 virus results, from a single sample in individuals who...

2009-10-23 19:00:00

SILVER SPRING, Md., Oct. 23 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration announced today that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital. (Logo:...

2009-10-16 15:08:00

MADISON, N.J., Oct. 16 /PRNewswire-FirstCall/ -- The U.S. Food and Drug Administration (FDA) today issued a second emergency use authorization (EUA) to Focus Diagnostics, the infectious disease diagnostics business of Quest Diagnostics Incorporated (NYSE: DGX), for its 2009 H1N1 influenza virus test. With the EUA, Focus Diagnostics is the only company in the U.S. to offer test kits for detecting the pandemic 2009 H1N1 virus that the FDA has authorized for emergency use by CLIA...

2009-10-15 14:58:00

SILVER SPRING, Md., Oct. 15 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today warned consumers to use extreme care when purchasing any products over the Internet that claim to diagnose, prevent, treat or cure the H1N1 influenza virus. The warning comes after the FDA recently purchased and analyzed several products represented online as Tamiflu (oseltamivir), which may pose risks to patients. (Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO ) One of the...


Word of the Day
omadhaun
  • A fool; a simpleton: a term of abuse common in Ireland and to a less extent in the Gaelic-speaking parts of Scotland.
This word is partly Irish in origin.