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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 56 Results
Analyte hCG, Urine Complexity waived Effective Date To 04/19/2014
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Document Parent Analyte Analyte Specialty Effective Date
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
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

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