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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte Urine hCG by visual color comparison tests Complexity waived Effective Date To 12/19/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
BTNX, Inc. Rapid Response HCG Midstream Pregnancy Test (Urine)  
CR140447 K062703 Urine hCG by visual color comparison tests Endocrinology 12/10/2014
BTNX, Inc. Rapid Response HCG Pregnancy Test Cassette (Urine/Serum)  
CR140447 K062703 Urine hCG by visual color comparison tests Endocrinology 12/10/2014
BTNX, Inc. Rapid Response HCG Pregnancy Test Cassette (Urine)  
CR140447 K062703 Urine hCG by visual color comparison tests Endocrinology 12/10/2014
BTNX, Inc Rapid Response HCG Pregnancy Test Strip (Urine)  
CR140447 K062703 Urine hCG by visual color comparison tests Endocrinology 12/10/2014
BTNX, Inc Rapid Response HCG Pregnancy Test Strip (Urine/Serum)  
CR140447 K062703 Urine hCG by visual color comparison tests Endocrinology 12/10/2014
QUIDEL QUICKVUE HCG URINE TEST  
CR140230 K020799 Urine hCG by visual color comparison tests Endocrinology 07/09/2014
Easy At Home Medical, LLC Easy@Home Early Pregnancy Test (cassette)  
CR140140 K043443 Urine hCG by visual color comparison tests Endocrinology 06/03/2014
Easy At Home Medical, LLC Easy@Home Early Pregnancy Test (strip)  
CR140140 K043443 Urine hCG by visual color comparison tests Endocrinology 06/03/2014
Easy At Home Medical, LLC Easy@Home Early Pregnancy Test (midstream)  
CR140140 K043443 Urine hCG by visual color comparison tests Endocrinology 06/03/2014
Express Diagnostics Int'l Inc. PregCheck+ hCG Pregnancy Serum/Urine Combo Test  
CR140060 K112101 Urine hCG by visual color comparison tests Endocrinology 05/01/2014

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