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Article: Quidel Gets 510(k) Clearance to Add 2009 H1N1 Influenza-A Virus Info to QuickVue Influenza A+B Test Package Insert.
- Article from:
- Entertainment Close-up
- Article date:
- September 24, 2009
CopyrightCOPYRIGHT 2009 Close-Up Media, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Quidel, a developer of point-of-care (POC) rapid diagnostic tests, announced it has received Special 510(k) clearance for an update to the company's QuickVue Influenza A+B test package insert to include reactivity with culture isolates of the 2009 H1N1 Influenza A virus.
Although the QuickVue Influenza A+B test has been shown to detect the 2009 influenza A (H1N1) virus, the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1) virus have not been established. The QuickVue Influenza A+B test kit can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.
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