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Article: Quidel Earns 510(k) Clearance to Add 2009 H1N1 Influenza-A Virus Info to QuickVue Influenza A+B Test Package Insert
- Article from:
- Wireless News
- Article date:
- September 25, 2009
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Wireless News
09-25-2009
Quidel Earns 510(k) Clearance to Add 2009 H1N1 Influenza-A Virus Info to QuickVue Influenza A+B Test Package Insert
Type: News
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 ...