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Agency clears QC-Hepatitis product for marketing. (QC-Hepatitis Quality Assurance Reagent for hepatitis testing of blood supply & blood products) (U.S. Food and Drug Administration)
U.S. FDA
North American Biologicals Inc. (NABI) announced that its QC-Hepatitis Quality Assurance Reagent for in vitro diagnostic use has been cleared for commercial distribution by the U.S. Food and Drug Administration (FDA).
QC-Hepatitis is the first multi-level, multi-constituent reagent cleared by the FDA to be used as an external control to promote the accuracy of hepatitis testing of the blood supply and blood products. In November 1991, NABI received FDA clearance of its QC-HIV Quality Assurance Reagent and will now be marketing both products to reference laboratories, blood bank laboratories and diagnostic product companies.
NABI …
