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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Streptococcus, Group A Complexity waived Effective Date To 11/28/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Cardinal Health Strep A Dipstick - Rapid Test  {Throat Swab Specimen} 
CR140208 K010582 Streptococcus, group A Bacteriology 07/09/2014
StrepAim  Specimen Type (Throat Swab)
CR140180 K983386 Streptococcus, group A Bacteriology 06/25/2014
Accustrip Strep A  Specimen Type (Throat Swab)
CR140122 K983386 Streptococcus, group A Bacteriology 05/23/2014
Poly stat Strep A Strip Test  Specimen Type (Throat Swab)
CR140122 K983386 Streptococcus, group A Bacteriology 05/23/2014
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

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