|
Approval for the architect core reagent kit, architect core calibrator and architect core controls. These devices are indicated for: architect core reagent kit: the architect core assay is a chemiluminescent microparticle immunoassay(cmia) for the qualitative detection of igg and igm antibodies to hepatitis b coreantigen (anti-hbc) in human adult and pediatric serum and plasma (dipotassium edta,lithium heparin, sodium heparin) and neonatal serum. it is intended as an aid in the diagnosis of acute, chronic, or resolved hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. architect core calibrator: the architect core calibrator is used for the calibration of the architect isystem when the system is used for the qualitative detection of igg and igm antibodies tohepatitis b core antigen (anti-hbc) with the architect core reagent kit. the performance of the architect core calibrator has not been established with any other anti-hbc assays. architect core controls: the architect core controls arc used for monitoring the performance of the architect i system when used for the qualitative detection of igg and igm antibodies to hepatitis b core antigen (anti-hbc) with the architect core reagent kit. theperformance of the architect core controls has not been established with any otheranti-hbc assays.
|
