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YY/T 1811-2022 PDF English

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YY/T 1811-2022: Complement 4 testing kit (immunoturbidimetric method)
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YY/T 1811-2022English179 Add to Cart 3 days [Need to translate] Complement 4 testing kit (immunoturbidimetric method)

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Basic data

Standard ID YY/T 1811-2022 (YY/T1811-2022)
Description (Translated English) Complement 4 testing kit (immunoturbidimetric method)
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Word Count Estimation 8,894
Issuing agency(ies) State Drug Administration

YY/T 1811-2022: Complement 4 testing kit (immunoturbidimetric method)


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
ICS 11.100.10 CCSC44 People's Republic of China Pharmaceutical Industry Standard Complement 4 Assay Kit (Immunoturbidimetry) Published on 2022-05-18 2023-06-01 Implementation Released by the State Drug Administration

foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1.Structure and Drafting Rules of Standardization Documents" drafted. Please note that some content of this document may be patented. Publication of this document Institutions do not assume responsibility for identifying patents. This document is proposed by the State Drug Administration. This document is under the jurisdiction of the National Standardization Technical Committee for Medical Clinical Laboratory and In Vitro Diagnostic Systems (SAC/TC136). This document was drafted by. Chongqing Medical Device Quality Inspection Center, Chongqing Zhongyuan Huiji Biotechnology Co., Ltd., Beijing Leadman Biochemical Co., Ltd., Roche Diagnostics (Shanghai) Co., Ltd., Shandong Brocade Biological Industry Co., Ltd. The main drafters of this document. He Lechun, Yi Weijing, Ren Yikun, Lai Liulian, Xie Qinghua. Complement 4 Assay Kit (Immunoturbidimetry)

1 Scope

This document specifies the requirements, test methods and identification, labels and instructions for use, packaging, Transport and storage. This document applies to the determination of complement 4 in human serum or plasma by immunoturbidimetry (immunotransmission turbidimetry and immune nephelometry). Kits for quantitative detection, including kits used on semi-automatic, fully automatic biochemical analyzers or specific protein analyzers.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document. GB/T 191 Graphical signs of packaging, storage and transportation GB/T 21415 Metrological traceability of measurement calibrators and control substance assignments in biological samples of in vitro diagnostic medical devices origin GB/T 29791.1 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 1.Terms, definitions and general Require GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use

3 Terms and Definitions

Terms and definitions defined in GB/T 29791.1-2013 apply to this document.

4 Requirements

4.1 Appearance Manufacturers should specify appropriate appearance requirements according to the packaging characteristics of products. Generally, the composition and properties of each component of the kit should be included; Packaging, labelling and other requirements. 4.2 Net content The net content of liquid reagents should not be less than the marked value. 4.3 Reagent blank absorbance The absorbance of the reagent blank should meet the requirements claimed by the manufacturer. NOTE. For immunoturbidimetry only. 4.4 Analytical Sensitivity Analytical sensitivity should meet the requirements claimed by the manufacturer. ...

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