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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 26 Results
Analyte Albumin Complexity waived Effective Date To 12/22/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Sekisui Diagnostics, LLC, OSOM ImmunoDip Urinary Albumin Test  
K043385   Albumin, urinary General Chemistry 02/16/2012
Sekisui Diagnostics, LLC OSOM ImmunoDip Urinary Albumin Test  
K011843   Albumin, urinary General Chemistry 01/26/2012
Siemens, CLINITEK Status+ Analyzer  
K091216   Microalbumin General Chemistry 01/04/2010
Siemens, CLINITEK Status Connect System  
K091216   Microalbumin General Chemistry 01/04/2010
Genzyme Diagnostics OSOM ImmunoDip Urinary Albumin Test  
K022538   Albumin, urinary General Chemistry 10/26/2009
Siemens Clinitek 50 Urine Chemistry Analyzer  
K960546   Microalbumin General Chemistry 09/14/2009
Siemens Clinitek Status Urine Chemistry Analyzer  
K031947   Microalbumin General Chemistry 03/05/2009
Abaxis Piccolo xpress Chemistry Analyzer  {Piccolo Renal Function Panel} (Whole Blood)
K022312   Albumin General Chemistry 12/04/2008
Abaxis Piccolo Blood Chemistry Analyzer  {Piccolo Renal Function Panel} (Whole Blood)
K022312   Albumin General Chemistry 12/04/2008
HemoCue Albumin 201 System  
K053253   Albumin, urinary General Chemistry 06/13/2008

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