This standard specifies the requirements, test methods, labels, instructions for use, packaging, transportation and storage of total protein determination kits (biuret method). This standard applies to kits for the quantitative detection of total protein in human serum (plasma) using the biuret method. It is based on the principle of spectrophotometry and includes manual reagents and reagents used on semi-automatic and fully-automatic biochemical analyzers. This standard does not apply to total protein determination kits using dry chemical methods.
YY/T 1444-2016 Referenced Document
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update