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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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11 to 20 of 38 Results
Analyte HDL Cholesterol Complexity waived Effective Date To 10/25/2014
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Document Parent Analyte Analyte Specialty Effective Date
Infopia USA LipidPro lipid profile and glucose measuring system  {LipidPro Lipid Profile test strips} 
K090405   HDL cholesterol General Chemistry 12/02/2009
Abaxis, Piccolo xpress Chemistry Analyzer  {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023640   HDL cholesterol General Chemistry 04/14/2008
Abaxis, Piccolo xpress Chemistry Analyzer  {Lipid Panel Reagent Disc} (Whole Blood)
K023640   HDL cholesterol General Chemistry 04/14/2008
Abaxis Piccolo Blood Chemistry Analyzer  {Lipid Panel Plus Reagent Disc} (Whole Blood)
K023640   HDL cholesterol General Chemistry 04/14/2008
Accutech CholesTrak HDL Cholesterol Home Test  
K072836   HDL cholesterol General Chemistry 01/08/2008
Polymer Technology Systems CardioChek PA Analyzer  {PTS PANELS CHOL+HDL Panel Test Strips} 
K071593   HDL cholesterol General Chemistry 10/15/2007
Polymer Technology Systems Cardiochek Brand Analyzer  {PTS PANELS CHOL+HDL Panel Test Strips} 
K071593   HDL cholesterol General Chemistry 10/15/2007
Polymer Technology Systems CardioChek PA Analyzer  {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507   HDL cholesterol General Chemistry 09/21/2007
Polymer Technology Systems Cardiochek Brand Analyzer  {PTS PANELS CHOL+HDL+GLUC Panel Test Strips} 
K071507   HDL cholesterol General Chemistry 09/21/2007
Cholestech LDX  {Lipid Profile - ALT (GPT)} (Whole Blood)
K922612   HDL cholesterol General Chemistry 05/16/2007

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