CLIA - Clinical Laboratory Improvement Amendments

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Analyte Bladder Tumor Associated Antigen Complexity waived

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Document	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