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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 23 Results
Analyte Influenza A Complexity waived
 
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Document Analyte Analyte Specialty Effective Date
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
K053126 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  (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
Clearview Exact II Influenza A & B Test  {For use with Nasal Swabs only.} 
K092349 Influenza A/B Virology 12/16/2011
BD Veritor System for Rapid Detection of Flu A + B  {For use with nasal and nasopharyngeal swabs} (Includes a Reader)
K112277 Influenza A/B Virology 12/09/2011

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