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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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11 to 20 of 61 Results
Analyte hCG, Urine Complexity waived Effective Date To 11/23/2014
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Document Parent Analyte Analyte Specialty Effective Date
Co-innovation Biotech Co., Ltd. One step hcg test midstream  
K132085   hCG, Urine Endocrinology 11/13/2013
UCP Biosciences Inc. Home Pregnancy Midstream Test  
K131236   hCG, Urine Endocrinology 11/07/2013
UCP Biosciences Inc. Home Pregnancy Dip/Card Strip  
K131236   hCG, Urine Endocrinology 11/07/2013
UCP Biosciences Inc. Home Pregnancy Cassette Test  
K131236   hCG, Urine Endocrinology 11/07/2013
Chemtrue┬« hCG Pregnancy Urine Dipstick  
K123844   hCG, Urine Endocrinology 05/30/2013
Chemtrue┬« hCG Pregnancy Urine Cassette Test  
K123844   hCG, Urine Endocrinology 05/30/2013
Chemtrue┬« hCG Combo (Serum/Urine) Cassette Test  
K123844   hCG, Urine Endocrinology 05/30/2013
EGENS One Step HCG Urine Pregnancy Test Kit (Midstream I)  
K123050   hCG, Urine Endocrinology 02/11/2013
EGENS One Step HCG Urine Pregnancy Test Kit (Cassette)  
K123050   hCG, Urine Endocrinology 02/11/2013
EGENS One Step HCG Urine Pregnancy Test Kit (Midstream II)  
K123050   hCG, Urine Endocrinology 02/11/2013

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