DevicePMAs@therightstef:P010050_S011 JSONTXT

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The device, as modified, will be marketed under the trade name immulite 2000 hbsag confirmatory kit and is indicated for: immulite 2000 hbsag confirmatory is intended for in vitro diagnostic use with immulite 2000 analyzers in conjunction with the immulite 2000 hbsag assay - for the confirmation of the presence of hepatitis b surface antigen (hbsag) in human serum or plasma (edta, heparinized, citrate) that were repeatedly reactive when tested by the immulite/ immulite 1000 hbsag assay or by the immulite 2000 hbsag 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