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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 44 Results
Analyte hCG, Urine Complexity waived
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Document Analyte Analyte Specialty Effective Date
Atlas Medical, ATLAS Home Pregnancy Test (Midstream Format)  
K102760 hCG, Urine Endocrinology 11/28/2011
IND Diagnostic Inc. One Step hCG Urine Pregnancy Test (Strip)  
K110889 hCG, Urine Endocrinology 06/23/2011
Siemens, CLINITEK Status Connect System  
K091216 hCG, Urine Endocrinology 01/04/2010
Siemens, CLINITEK Status+ Analyzer  
K091216 hCG, Urine Endocrinology 01/04/2010
Siemens Clinitek Status Urine Chemistry Analyzer  
K032563 hCG, Urine Endocrinology 01/26/2009
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test  {midstream} (OTC)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test  {Cassette} (OTC)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test  {strip} (OTC)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test  {Cassette} (Professional Use)
K071930 hCG, Urine Endocrinology 12/19/2007
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test  {midstream} (professional)
K071930 hCG, Urine Endocrinology 12/19/2007

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