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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Analyte hCG, Urine Complexity waived
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Document Analyte Analyte Specialty Effective Date
Blue Cross Biomedical Company One Step hCG Urine Pregnancy Test  {strip} (professional)
K071930 hCG, Urine Endocrinology 12/19/2007
Fisher HealthCare Sure-Vue Serum/Urine hCG-STAT  
K062361 hCG, Urine Endocrinology 04/02/2007
Bayer Clinitek Status Urine Chemistry Analyzer  
K032563 hCG, Urine Endocrinology 03/16/2007
Innovacon hCG Ultra Test Device  
K062361 hCG, Urine Endocrinology 11/01/2006
Ani Biotech Oy MySet Pregnancy Test  
K053138 hCG, Urine Endocrinology 03/03/2006
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Cassette  
K060019 hCG, Urine Endocrinology 02/22/2006
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Midstream  
K060019 hCG, Urine Endocrinology 02/22/2006
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Strip  
K060019 hCG, Urine Endocrinology 02/22/2006
Artron One-Step Pregnancy Test  
K060019 hCG, Urine Endocrinology 02/22/2006
Acon +/- Pregnancy Test  
K050546 hCG, Urine Endocrinology 05/23/2005

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