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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Influenza A/B Complexity waived Effective Date To 09/30/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Sofia Analyzer and Influenza A+B FIA  
K112177   Influenza A/B Virology 12/13/2013
Sofia Analyzer and Influenza A+B FIA  
CW130003 K112177 Influenza A/B Virology 12/13/2013
Henry Schein OneStep+Influenza A&B Test  
K103610   Influenza A/B Virology 02/13/2013
Alere BinaxNOW Influenza A & B Card  Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens
K092223   Influenza A/B Virology 09/13/2012
Alere BinaxNOW Influenza A & B Card  Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens
K062109   Influenza A/B Virology 09/13/2012
Alere BinaxNOW Influenza A & B Card  Nasopharyngeal (Np) Swab And Nasal Wash/Aspirate Specimens
K053126   Influenza A/B Virology 09/13/2012
Alere BinaxNOW Influenza A & B Card  (Nasal Wash/Aspirate Specimens)
K041049   Influenza A/B Virology 09/13/2012
Sofia Analyzer and Influenza A+B FIA  {For use with nasal swabs and nasopharyngeal swabs} 
K112177   Influenza A/B Virology 04/20/2012
Alere Influenza A & B Test  {For use with Nasal Swabs only.} 
K092349   Influenza A/B Virology 01/27/2012
BD Veritor System for Rapid Detection of Flu A + B  {For use with nasal swabs and nasopharyngeal swabs} (Includes a reader)
K112277   Influenza A/B Virology 01/04/2012

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