DevicePMAs@therightstef:P010050_S011 JSONTXT 11 Projects

Approval for an automated means of confirmation testing on-board the immulite 2000 immunoassay analyzer. 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 assay.