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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 6 of 6 Results
Analyte Bladder Tumor Associated Antigen Complexity waived Effective Date To 12/21/2014
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Document Parent Analyte Analyte Specialty Effective Date
LifeSign Status BTA  
K974845   Bladder tumor associated antigen General Immunology 05/15/2012
Alere NMP22 BladderChek Test  {Prescription Home Use} 
K021231   Bladder tumor associated antigen General Immunology 06/22/2011
Alere NMP22 BladderChek Test  {Professional Use} 
K021231   Bladder tumor associated antigen General Immunology 06/22/2011
MATRITECH BLADDERCHEK  (Prescription Home Use)
K021231   Bladder tumor associated antigen General Immunology 08/12/2002
MATRITECH BLADDERCHEK  (Professional Use)
K021231   Bladder tumor associated antigen General Immunology 08/12/2002
Bion Diagnostic Sciences BTA stat Test  (for home use)
K974845   Bladder tumor associated antigen General Immunology 02/04/1999

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