This standard specifies the requirements for apolipoprotein AI determination reagents (boxes), test methods, identification, labels and instructions for use, packaging, transportation and storage. This standard applies to reagents (boxes) for quantitative detection of apolipoprotein AI in human serum or plasma using immunoturbidimetry (transmission method), including reagents used on manual, semi-automatic, and fully automatic biochemical analyzers.
YY/T 1450-2016 Referenced Document
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update