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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 61 Results
Analyte hCG, Urine Complexity waived Effective Date To 12/21/2014
 
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Document Parent Analyte Analyte Specialty Effective Date
EKLA Corp. NOVAPLUS S10 hCG Pregnancy Serum/Urine Combo Test  (Test Strip)
CR140209 K132834 hCG, Urine Endocrinology 07/09/2014
EKLA Corp. NOVAPLUS S10 hCG Pregnancy Serum/Urine Combo Test  (Cassette)
CR140209 K132834 hCG, Urine Endocrinology 07/09/2014
BTNX Inc. Rapid Response Human Chorionic Gonadotropin hCG Test (Urine/Serum)  (Test Strip)
CR140213 K132834 hCG, Urine Endocrinology 06/26/2014
BTNX Inc. Rapid Response Human Chorionic Gonadotropin hCG Test (Urine/Serum)  (Cassette)
CR140213 K132834 hCG, Urine Endocrinology 06/26/2014
EKLA Corportation, Novaplus hCG Pregnancy Serum/Urine Combo Test  
CR140165 K112101 hCG, Urine Endocrinology 06/06/2014
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

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