DevicePMAs@therightstef:P060034_S000 11 Projects
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Approval for the bio-rad monolisa anti-hbc igm eia. The device is indicated for: the bio-rad monolisa anti-hbc igm eia is an enzyme immunoassay intended for use in the qualitative detection of igm antibodies to hepatitis b core antigen (anti-hbc igm) in human serum or plasma (potassium edta, sodium citrate, acd [acid citrate dextrose], lithium heparin and sodium heparin). Assay results may be used with other hbv serological markers for the laboratory diagnosis of hbv disease associated with hbv infection.
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