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Abbott announced that it has received premarket approval from the U.S. Food and Drug Administration for ARCHITECT CORE, an automated hepatitis B test for use on its ARCHITECT i 2000 and i 2000SR immunoassay testing instruments. ARCHITECT CORE is a chemiluminescent microparticle immunoassay for the qualitative detection of IgG and IgM antibodies to hepatitis B core antigen in human adult and pediatric serum and plasma and neonatal serum. It is intended as an aid in diagnosis of acute, chronic or resolved hepatitis B virus infection in conjunction with other laboratory results and clinical information.

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