(267 days)
The Diazyme Ferritin Assay is for the quantitative determination of ferritin in human serum. K2EDTA plasma, and lithium heparin plasma on Hitachi 917 analyzer. For in vitro diagnostic use only.
The Diazyme Ferritin Calibrator Set is intended for use in the Diazyme Ferritin Assay. For in vitro diagnostic use only.
The Diazyme Ferritin Control Set is intended for use as quality controls for the Diazyme Ferritin Assay. For in vitro diagnostic use only.
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§ 866.5340 Ferritin immunological test system.
(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).