This Standard specifies the classification, requirements, test method, marking, instructions for use, packaging, transportation and storage for C-reactive protein testing kits. This Standard applies to kits for quantitative determination of C-reactive protein in blood sample (hereinafter referred to as CRP kits) based on the basic principle of antibody-antigen reaction, including the labeling quantitation immune method [such as electrochemiluminescence] and immunoturbidimetry (such as turbidimetric immunoassay and latex particle-enhanced turbidimetric immunoassay). This Standard does not apply to. a) evaluate the calibration products and quality control products of C-reactive protein; b) all types of colloidal immunogold labeling test paper.
Basic Data
Standard ID
YY/T 1513-2017 (YY/T1513-2017)
Description (Translated English)
C-reactive protein testing kit
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
10,161
Date of Issue
2017-03-28
Date of Implementation
2018-04-01
Regulation (derived from)
China Food and Drug Administration Announcement 2017 No. 38
