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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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1 to 10 of 56 Results
Analyte hCG, Urine Complexity waived Effective Date To 04/21/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
Wunder Pregnancy Test  
K130456   hCG, Urine Endocrinology 04/09/2014
Polymed Therapeutics Fastep s10 hcg serum/urine combo test  (test strip)
K132834   hCG, Urine Endocrinology 03/19/2014
Polymed Therapeutics Fastep s10 hcg serum/urine combo test  (cassette)
K132834   hCG, Urine Endocrinology 03/19/2014
Co-innovation Biotech Co., Ltd. One step hcg test strip  
K132085   hCG, Urine Endocrinology 11/13/2013
Co-innovation Biotech Co., Ltd. One step hcg test cassette  
K132085   hCG, Urine Endocrinology 11/13/2013
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

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