YY/T 1252-2015Total IgE quantitative labelling immunoassay kit (English PDF)

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules.

1 Scope

This standard specifies the total IgE labeled immunosorbent assay kit for quantitative quality requirements, test methods, instructions for use, marking, labeling and package Equipment, transportation and storage.

This standard applies to the quantitative determination of total IgE were labeled immunoassay kit (hereinafter referred to as the kit). Include enzyme labels, of Chemiluminescent label and the like methods for the capture antibody to microtiter plates, tubes, magnetic particles, beads and plastic beads as the carrier coating antibody, quantitative measurement Total IgE immunoassay assay kit. This standard does not apply to.

a) colloidal gold-labeled total IgE test strip;

b) radiolabeled with 125I and other types of RIA or IRMA kit.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 191 Packaging - Pictorial signs Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements Category 3 The kit can be divided according to different labeling methods ELISA, chemiluminescence, immunofluorescence and other kit, according to the solid support Different type can be divided into microplates, tubes, magnetic particles, beads and plastic beads as the carrier of the kit; based on the operation can be divided into hand Duplex operation method and apparatus for automatic operation method of the kit.

4 Requirements