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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte HIV-1 antibody Complexity waived Effective Date To 09/30/2014
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Document Parent Analyte Analyte Specialty Effective Date
bioLytical INSTI HIV-1 Antibody Test  (Fingerstick Whole Blood)
BP090032   HIV-1 antibody General Immunology 07/20/2012
TRINITY BIOTECH UNI-GOLD RECOMBIGEN HIV TEST  (Fingerstick, Venipuncture Whole Blood)
BP030025   HIV-1 antibody General Immunology 11/05/2004
TRINITY BIOTECH UNI-GOLD RECOMBIGEN HIV TEST  WHOLE BLOOD (VENIPUNCTURE)
BP030025   HIV-1 antibody General Immunology 06/23/2004
ORASURE TECHNOLOGIES ORAQUICK RAPID HIV-1 ANTIBODY TEST  (Fingerstick, Venipuncture Whole Blood)
BP010047   HIV-1 antibody General Immunology 09/30/2003
ORASURE ORAQUICK RAPID HIV-1 TEST  
BP010047   HIV-1 antibody General Immunology 01/31/2003

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