Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increase in sample turbidity, measured at 604 nm, is directly proportional to the concentration of apolipoprotein B in the sample.

Reason: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.

Code information: All IFU's

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