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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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21 to 30 of 61 Results
Analyte hCG, Urine Complexity waived Effective Date To 10/25/2014
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Document Parent Analyte Analyte Specialty Effective Date
EGENS One Step HCG Urine Pregnancy Test Kit (Strip)  
K123050   hCG, Urine Endocrinology 02/11/2013
SPD Swiss Precision Diagnostics GmbH Clearblue Advanced Pregnancy Test with Weeks Estimator  
K112870   hCG, Urine Endocrinology 12/11/2012
Alere San Diego Inc, Alere hCG Cassette (25 mIU/mL)  
K993317   hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc, Alere hCG Dipstick (25 mIU/mL)  
K993203   hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc, Alere hCG Combo Cassette (25 mIU/mL)  
K993065   hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc. Alere hCG Cassette (20 mIU/mL)  
K062361   hCG, Urine Endocrinology 01/11/2012
Alere San Diego Inc, Alere hCG Combo Cassette (20/10 mIU/mL)  
K062361   hCG, Urine Endocrinology 01/11/2012
Atlas Medical, ATLAS Home Pregnancy Test (Midstream Format)  
K102760   hCG, Urine Endocrinology 11/28/2011
IND Diagnostic Inc. One Step hCG Urine Pregnancy Test (Strip)  
K110889   hCG, Urine Endocrinology 06/23/2011
Siemens, CLINITEK Status+ Analyzer  
K091216   hCG, Urine Endocrinology 01/04/2010

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