This standard specifies the terminology, requirements, test methods, labels, instructions for use, packaging, transportation and storage of ischemia-modified albumin determination reagents (kits) (albumin-cobalt binding method). This standard applies to reagents (kits) for the quantitative detection of ischemia-modified albumin (IMA) in human serum using the albumin-cobalt binding method. It is based on the principle of spectrophotometry and includes manual reagents and semi-automatic and fully automatic biochemical analyzers. reagents used.
YY/T 1461-2016 Referenced Document
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 1461-2016 history
2016YY/T 1461-2016 Ischemia-modified albumin test reagent