This document specifies the requirements for interleukin-6 (hereinafter referred to as IL-6) assay kit (labeled immunoassay method), test methods and identification, labeling and instructions for use, packaging, transportation and storage. This document is applicable to kits for the quantitative determination of IL-6 content in human serum, plasma or whole blood based on the reaction principle of labeled immunity. The methodologies include fluorescent labeling immunochromatography, chemiluminescence, etc. This document does not apply to the evaluation of IL-6 calibrators and quality controls.