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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 19 Results
Analyte Respiratory Syncytial Virus Complexity waived Effective Date To 07/29/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Sofia RSV  
CW130007 K130398 Respiratory syncytial virus Virology 05/30/2014
BD Veritor System for Rapid Detection of RSV  {For use with nasopharyngeal specimens} (Includes a reader)
K132456   Respiratory syncytial virus Virology 03/18/2014
BD Veritor System for Rapid Detection of RSV  {For use with nasopharyngeal specimens} (Includes a reader)
CW130005 K132456 Respiratory syncytial virus Virology 03/18/2014
Alere BinaxNOW RSV Card  
K032166   Respiratory syncytial virus Virology 09/13/2012
Alere BinaxNOW RSV Card  
K021687   Respiratory syncytial virus Virology 09/13/2012
BTNX Inc. Rapid Response RSV Test  
K022845   Respiratory syncytial virus Virology 01/03/2011
Quidel QuickVue RSV Test  
K070747   Respiratory syncytial virus Virology 09/25/2008
Quidel QuickVue RSV Test  
K061008   Respiratory syncytial virus Virology 09/25/2008
Quidel QuickVue RSV Test  
K070747   Respiratory syncytial virus Virology 02/25/2008
Quidel QuickVue RSV Test  
K061008   Respiratory syncytial virus Virology 02/25/2008

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