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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 09/01/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
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
Heritage House '76 Quick and Clear II Pregnancy Test  
CR140041 K980531 Urine hCG by visual color comparison tests Endocrinology 04/28/2014
Courageous CHOICE Pregnancy Test  
K984075   Urine hCG by visual color comparison tests Endocrinology 03/19/2014
StanbioQuPID One-Step Pregnancy Test  
K020378   Urine hCG by visual color comparison tests Endocrinology 03/19/2014
StanbioQuPID Plus One-step Pregnancy Test  
K020378   Urine hCG by visual color comparison tests Endocrinology 03/19/2014
Stanbio True 20 Plus One-Step Pregnancy Test  
K020378   Urine hCG by visual color comparison tests Endocrinology 03/19/2014

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