YY/T 1257-2015Free-beta-subunit of human chorionic gonadotropin 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 free beta subunit of human chorionic gonadotropin labeled immunosorbent assay kit for quantitative classification, requirements, test side France, logos, labels, brochures, packaging, transportation and storage.

This standard applies to the determination of free human chorionic gonadotropin beta-subunit kit double antibody sandwich method for the principle quantitatively. This standard does not apply to.

a) with colloidal gold or other qualitative or semi-quantitative determination of marker free beta subunit of human chorionic gonadotropin agents (such as. Test strip, etc.);

b) all kinds of free beta subunit of human chorionic gonadotropin radiolabelled with 125I and other RIA or IRMA test Cartridge.

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 Labeling methods can be divided according to the different enzyme label, (electro) chemiluminescent labels, (time-resolved) fluorescent labels; not according

to the solid support The same type can be divided into microplates, tubes, magnetic particle, microsphere beads and plastic beads and the like; depending on the operation process can be divided into manual method and apparatus Automatic operation of law.

4 Requirements