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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 106 Results
Analyte Streptococcus, Group A Complexity waived Effective Date To 04/18/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
BD Veritor¿ System for Rapid Detection of Group A Strep  {direct from throat swab} 
CW130001 K122718 Streptococcus, group A Bacteriology 02/18/2014
Poly stat Strep A Flip Test  
K040708   Streptococcus, group A Bacteriology 07/29/2013
Henry Schein OneStep Pro+ Strep A Cassette  
K040708   Streptococcus, group A Bacteriology 07/03/2013
BinaxNOW Strep A Card  (direct from throat swab)
K960712   Streptococcus, group A Bacteriology 01/16/2013
Mooremedical Strep A Rapid Test - Dipstick  
K010582   Streptococcus, group A Bacteriology 06/07/2012
McKesson Strep A Test - Twist  
K023766   Streptococcus, group A Bacteriology 03/23/2012
Mckesson Strep A Test - Dipstick  
K010582   Streptococcus, group A Bacteriology 03/23/2012
Sekisui Diagnostics, LLC OSOM Strep A Test  (direct from throat swab)
K961423   Streptococcus, group A Bacteriology 03/01/2012
Sekisui Diagnostics, LLC, OSOM ULTRA STREP A  
K043385   Streptococcus, group A Bacteriology 02/16/2012
Sekisui Diagnostics, LLC, OSOM Ultra Srep A Test  
K992658   Streptococcus, group A Bacteriology 02/03/2012

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