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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments

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Analyte HIV Antibodies Complexity waived Effective Date To 03/28/2015
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Document Parent Analyte Analyte Specialty Effective Date
OraSure Technologies, OraQuick In-Home HIV Test  (Oral Fluid)
BP120001   HIV antibodies General Immunology 07/20/2012
Chembio HIV 1/2 STAT-PAK Assay  (Fingerstick, Venipuncture Whole Blood)
BP050010   HIV antibodies General Immunology 11/20/2006