This standard specifies the requirements for lipoprotein(a) determination kits, test methods, identification, labels and instructions for use, packaging, transportation and storage. This standard applies to kits for the quantitative detection of lipoprotein (a) in human serum or plasma using immunoturbidimetry (transmission method), including manual reagents and reagents used on semi-automatic and fully-automatic biochemical analyzers.
YY/T 1448-2016 Referenced Document
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update