This standard specifies the requirements, test methods, markings, labels, instructions for use, packaging, transportation and storage of ferritin quantitative detection reagents (boxes). This standard applies to reagents (kits) for the quantitative detection of ferritin in blood samples or urine samples [hereinafter referred to as "Ferr-reagents (kits)"] based on the antigen-antibody reaction as the basic principle. The kit methodology includes quantitative labeling immunoassay methods. [Such as enzyme-linked immunosorbent assay (ELISA), time-resolved fluorescence immunoassay, (electro)chemiluminescence method, etc.] and immunoturbidimetric methods (such as immunoturbidimetric method, latex-enhanced immunoturbidimetric method, etc.). This standard is not applicable to the evaluation of ferritin calibrators and quality control materials.
YY/T 1456-2016 Referenced Document
GB/T 191 Packaging.Pictorial marking for handling of goods
GB/T 21415-2008 In vitro diagnostic medical devices.Measurement of quantities in biological samples.Metrological traceability of values assigned to calibrators and control materials
YY/T 0466.1 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements*， 2023-09-05 Update
YY/T 1456-2016 history
2016YY/T 1456-2016 Human ferritin quantitative test reagent