DevicePMAs@therightstef:P060009_S000 / 0-9
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Approval for the abbott axsym core-m 2.0 and axsym core-m 2.0 controls. These devices are indicated for: theaxsym core-m 2.0 is a microparticle enzyme immunoassay (meia) intended for the in vitro qualitative detection of igm antibody to hepatitis b virus core antigen (igm anti-hbc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium edta, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes). the assay is used as an aid in the diagnosis of acute or recent hepatitis b virus (hbv) infection in conjunction with other laboratory results and clinical information. the axsym core-m 2.0 controls are used for monitoring the performance of the axsym system (reagent and instrument) when used for the qualitative detection of igm antibody to hepatitis b virus core antigen (igm anti hbc) when using the axsym core-m 2.0 reagent pack. the performance of the axsym core-m 2.0 controls has not been established with any other anti-hbc assays.
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