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Article: Quidel Issues Clarification Regarding Special 510(k) Clearance to Add 2009 H1N1 Influenza A Virus Reactivity Information to the QuickVue Influenza A+B Test Package Insert.(Correction notice)
- Article from:
- Business Wire
- Article date:
- September 18, 2009
CopyrightCOPYRIGHT 2009 Business Wire. 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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SAN DIEGO -- Quidel Corporation (NASDAQ: QDEL), a global leader in point-of-care (POC) rapid diagnostic tests, issues clarification regarding the Special 510(k) clearance for an update to the Company's QuickVue[R] Influenza A+B test package insert. A news wire agency released misleading information stating there is a new swine flu version of Quidel's QuickVue Influenza A+B test and that FDA approved this new version. This statement is incorrect.
Quidel did obtain Special 510(k) clearance for an update to the QuickVue Influenza A+B test package insert to include reactivity with culture isolates of the 2009 H1N1 Influenza A virus. Although the QuickVue Influenza ...