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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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41 to 50 of 56 Results
Analyte hCG, Urine Complexity waived Effective Date To 04/16/2014
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Document Parent Analyte Analyte Specialty Effective Date
Artron One-Step Human Chorionic Gonadotropin (hCG) Pregnancy Test Midstream  
K060019   hCG, Urine Endocrinology 02/22/2006
Acon +/- Pregnancy Test  
K050546   hCG, Urine Endocrinology 05/23/2005
Access Bio Inc. CareStart Pregnancy Test  
K032159   hCG, Urine Endocrinology 02/28/2005
Access Bio Inc. CareStart PLUS Pregnancy Test  
K032159   hCG, Urine Endocrinology 02/28/2005
BIOTECH ATLANTIC INC UNIMARK ONE STEP HOME PREGNANCY TEST DEVICE  (cassette)
K032992   hCG, Urine Endocrinology 12/09/2003
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

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