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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte hCG, Urine Complexity waived
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Document Analyte Analyte Specialty Effective Date
Access Bio Inc. CareStart PLUS Pregnancy Test  
K032159 hCG, Urine Endocrinology 02/28/2005
Access Bio Inc. CareStart 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 ACCUSTRIP HCG-COMBO MODEL, HCG-005  
K032987 hCG, Urine Endocrinology 12/09/2003
UNOTECH DIAGNOSTICS ACCUTEST HCG-COMBO MODEL,HCG-004  
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 DEVICE  
K013194 hCG, Urine Endocrinology 10/15/2001
BIOTECH ATLANTIC INC UNIMARK HCG COMBO PREGNANCY TEST STRIP  
K013194 hCG, Urine Endocrinology 10/15/2001

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