Apolipoprotein A-I (Apo A1) IVD, kit, nephelometry/turbidimetry

This category includes in vitro diagnostic (IVD) kits designed to measure the concentration of apolipoprotein A-I (Apo A1) in patient specimens such as blood serum or plasma. These kits use nephelometry or turbidimetry methods to quantify Apo A1, a major protein component of high-density lipoprotein (HDL), which is clinically useful in assessing cardiovascular disease risk and lipid metabolism disorders.

Devices in this category are supplied as reagent kits containing all necessary components for the assay and are intended for use with compatible clinical chemistry analyzers. They are regulated as in vitro diagnostic medical devices and must conform to applicable performance, safety, and labeling requirements based on their intended use and method of detection.