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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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51 to 60 of 61 Results
Analyte hCG, Urine Complexity waived Effective Date To 11/28/2014
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Document Parent Analyte Analyte Specialty Effective Date
UNOTECH DIAGNOSTICS ACCUTEST HCG-COMBO MODEL,HCG-004  
K032987   hCG, Urine Endocrinology 12/09/2003
UNOTECH DIAGNOSTICS ACCUSTRIP HCG-COMBO MODEL, HCG-005  
K032987   hCG, Urine Endocrinology 12/09/2003
ACON QUIK-CHECK II MIDSTREAM HOME PREGNANCY TEST  
K032510   hCG, Urine Endocrinology 09/15/2003
SA SCIENTIFIC SURE-VUE URINE HCG  
K010593   hCG, Urine Endocrinology 05/01/2003
ADVANCED DIAGNOSTICS INC MIDSTREAM PREGNANCY TEST  
K023037   hCG, Urine Endocrinology 04/15/2003
BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST STRIP  
K013194   hCG, Urine Endocrinology 10/15/2001
BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST DEVICE  
K013194   hCG, Urine Endocrinology 10/15/2001
CHEMBIO HCG QUICKSTIX  
K011551   hCG, Urine Endocrinology 08/29/2001
SA SCIENTIFIC SURE-VUE SERUM/URINE HCG-STAT  
K990684   hCG, Urine Endocrinology 07/03/2001
SA SCIENTIFIC HEB ONE-STEP PREGNANCY TEST  
K991193   hCG, Urine Endocrinology 07/02/2001

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