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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 04/23/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
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
Ramco Quick-Trak Combi Test One-Step Pregnancy Test  
K020378   Urine hCG by visual color comparison tests Endocrinology 03/19/2014
Cen-Med Enterprises Elite Plus hCG Pregnancy Serum/Urine Combo Test  
K112101   Urine hCG by visual color comparison tests Endocrinology 01/28/2014
Medline Pregnancy Combo Test (Cassette)  
K984077   Urine hCG by visual color comparison tests Endocrinology 08/28/2013
Medimpex United Inc. QTEST hCG Pregnancy Serum/Urine Combo Test  
K112101   Urine hCG by visual color comparison tests Endocrinology 08/22/2013
Medimpex United, Inc. QTEST At-Home Pregnancy Test  
K122907   Urine hCG by visual color comparison tests Endocrinology 08/01/2013
Chemtron Biotech, Inc., Chemtrue hCG Pregnancy Urine Midstream Test  
K131931   Urine hCG by visual color comparison tests Endocrinology 07/29/2013

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