This Standard specifies the requirements, test methods, label and operating manual, package, transportation and storage of myoglobin assay kit (immunoturbidimetric method). This Standard is applicable to the assay kit for the quantitative detection (hereinafter referred to as assay kit) of myoglobin in human serum or plasma by the immunoturbidimetric method (transmission method); it includes reagents used on the manual, semi-automatic, fully automatic biochemical analyzers.
Basic Data
Standard ID
YY/T 1528-2017 (YY/T1528-2017)
Description (Translated English)
Myoglobin Assay Kit (Immunoturbidimetric Method)
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
8,87
Date of Issue
2017-03-28
Date of Implementation
2018-04-01
Regulation (derived from)
China Food and Drug Administration Announcement 2017 No. 38
