DevicePMAs@therightstef:P080023_S000
Annnotations
{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P080023_S000","sourcedb":"DevicePMAs@therightstef","sourceid":"P080023_S000","text":"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 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