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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
 
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Document Analyte Analyte Specialty Effective Date
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  
K992658 Streptococcus, Group A Bacteriology 02/16/2012
Sekisui Diagnostics, LLC, OSOM Ultra Srep A Test  
K992658 Streptococcus, Group A Bacteriology 02/03/2012
LifeSign, LLC Status Strep A  
K983386 Streptococcus, Group A Bacteriology 12/06/2011
Binax Clearview Advanced Strep A  {direct from throat swab} 
K091489 Streptococcus, Group A Bacteriology 06/24/2011
ProAdvantage by NDC Strep A Test  
K010582 Streptococcus, Group A Bacteriology 04/21/2011

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