This document specifies the requirements, identification, labeling and instructions for use, packaging, transportation and storage of detection reagent kits for enzyme-linked immunoabsorbent assay, and describes the corresponding test methods. This document applies to quantitative or qualitative detection reagent kits (hereinafter referred to as “reagent kits”) based on the principle of enzyme-linked immunoabsorbent assay in medical laboratories.
Basic Data
Standard ID
YY/T 1183-2024 (YY/T1183-2024)
Description (Translated English)
Detection reagent kit for enzyme-linked immunoabsorbent assay
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100.10
Word Count Estimation
14,196
Date of Issue
2024-09-29
Date of Implementation
2025-10-15
Older Standard (superseded by this standard)
YY/T 1183-2010
Issuing agency(ies)
State Drug Administration
Summary
This standard specifies the requirements, identification, labeling and instructions for use, packaging, transportation and storage of enzyme-linked immunosorbent assay test kits, and specifies the corresponding test methods. This standard applies to quantitative or qualitative test kits that are tested in medical laboratories based on the principle of enzyme-linked immunosorbent assay.
