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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Influenza B Complexity waived Effective Date To 04/24/2014
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Document Parent Analyte Analyte Specialty Effective Date
BTNX, Inc. Rapid Response Influenza B Test Cassette  
K041439   Influenza B Virology 01/10/2011
EarlyDetect Pro Influenza B Test  
K041439   Influenza B Virology 03/10/2009
Quidel QuickVue Influenza A+B Test  
K031899   Influenza B Virology 09/25/2008
SA Scientific SAS Influenza B Test  
K041439   Influenza B Virology 11/23/2005
Quidel QuickVue Influenza A+B Test  
K031899   Influenza B Virology 02/06/2004
Binax NOW Flu B Test  {Nashal Wash, Nasopharyngeal} 
K021646   Influenza B Virology 05/08/2003

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