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clearance with a Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver from the US Food and Drug Administration (FDA) for its cobas liat sexually transmitted infection (STI) multiplex ...
The Test: The OraQuick Rapid HIV-1/2 Antibody Test was originally approved for use in whole blood in November 2002 and received a CLIA waiver for expanded use in this setting in January 2003.