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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 9 of 9 Results
Analyte Luteinizing Hormone (LH) Complexity waived Effective Date To 11/25/2014
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Document Parent Analyte Analyte Specialty Effective Date
Wondfo Biotech Co. Ltd, Wondfo One Step Ovulation Urine Test (Cassette)  
CR140141 K052766 Luteinizing hormone (LH) Endocrinology 08/06/2014
Wondfo Biotech Co. Ltd, Wondfo One Step Ovulation Urine Test (Strip)  
CR140141 K052766 Luteinizing hormone (LH) Endocrinology 08/06/2014
EASY at Home Medical LLC, Easy@Home Ovulation Test (Cassette)  
CR140141 K052766 Luteinizing hormone (LH) Endocrinology 08/06/2014
EASY at Home Medical LLC, Easy@Home Ovulation Test (Strip)  
CR140141 K052766 Luteinizing hormone (LH) Endocrinology 08/06/2014
EASY at Home Medical LLC, Easy@Home Ovulation Test (Midstream)  
CR140141 K052766 Luteinizing hormone (LH) Endocrinology 08/06/2014
Wondfo Biotech Co. Ltd, Wondfo One Step Ovulation Urine Test (Midstream)  
CR140141 K052766 Luteinizing hormone (LH) Endocrinology 08/06/2014
Saless Enterprises New Choice Ovulation Urine Test (Cassette)  
X110078   Luteinizing hormone (LH) Endocrinology 06/14/2011
CHEMBIO SURE CHECK OVULATION PREDICTOR  
K010244   Luteinizing hormone (LH) Endocrinology 07/20/2001
INVERNESS MEDICAL EARLY OVULATION PREDICTOR  (stick)
K002867   Luteinizing hormone (LH) Endocrinology 10/23/2000

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