DevicePMAs@therightstef:P040018_S000 JSONTXT

{"target":"https://pubannotation.org/docs/sourcedb/DevicePMAs@therightstef/sourceid/P040018_S000","sourcedb":"DevicePMAs@therightstef","sourceid":"P040018_S000","text":"Approval for the advia centaur hav igm. Hav igm readypack reagents: this device is indicated for use for the advia centaur hav igm assay and is an in vitro diagnostic immunoassay for the qualitative determination of igm response to the hepatitis a virus (hav) in human serum or plasma (potassium edta, lithium or sodium heparinized) using the advia centaur system. The assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis a virus. Hav igm quality control materials: the controls are indicated for in vitro diagnostic use in monitoring the performance of the hav igm assay on the advia centaur systems. 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