Approval of the adiva centaur anti-hbe2 (ahbe2) assay. The qualitative detection of antibodies to the e antigen of the hepatitis b virus (hbv) in human pediatric (2–21 years old) and adult serum, edta plasma, or lithium heparin plasma using the advia centaur systems (xp/xpt/cp). Assay results, in conjunction with other laboratory results and clinical information may be used as an aid in the diagnosis of hepatitis b virus (hbv) infection in patients with signs or symptoms of hepatitis b infection, or with risk factors for hbv infection, or with known hbv infection. Results of the assay, in conjunction with other diagnostic information, may be used to aid in determining hbv seroconversion.
|Device||ADVIA Centaur Anti-HBe2 (aHBe2) assay|
|Generic Name||Test, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)|
|Applicant||Siemens Healthcare Diagnostics, Inc.|
|Applicant Address||Siemens Healthcare Diagnostics, Inc. 511 Benedict Avenue tarrytown, NY 10591-5097|
|Supplement Number||Date||Supplement Type|