GB/T 40983-2021 English PDFUS$189.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. GB/T 40983-2021: Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) IgG antibody detection kit Status: Valid
Basic dataStandard ID: GB/T 40983-2021 (GB/T40983-2021)Description (Translated English): Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) IgG antibody detection kit Sector / Industry: National Standard (Recommended) Classification of Chinese Standard: C44 Word Count Estimation: 10,152 Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration GB/T 40983-2021: Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) IgG antibody detection kit---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. Quality assessment requirements for severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) IgG antibody detection kit ICS 11.100.10 CCSC44 National Standards of People's Republic of China Novel coronavirus IgG antibody detection kit Quality evaluation requirements Released on 2021-11-26 2022-03-01 implementation State Administration for Market Regulation Issued by the National Standardization Management Committee ForewordThis 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" Drafting. Please note that some of the contents of this document may involve patents. The issuing agency of this document is not responsible for identifying patents. This document was proposed by the State Drug Administration. This document is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this document. China Institute for Food and Drug Control, Chinese People's Liberation Army General Hospital, National Medical Products Administration Instrument Technology Evaluation Center, Beijing Institute of Medical Device Inspection, Institute of Pathogenic Biology, Chinese Academy of Medical Sciences, Zhuhai Lizhu Reagent Co., Ltd. The company, Boo Saisi (Chongqing) Biotechnology Co., Ltd., and Dana (Tianjin) Biotechnology Co., Ltd. The main drafters of this document. Shi Dawei, Xia Deju, Hu Jinjun, Xu Sihong, Yang Zhen, He Kunlun, Zhang Chunyan, Chen Tingting, Dai Leiying, Ren Lili, Dai Junying, Liu Ping, Zhou Zeqi. Novel coronavirus IgG antibody detection kit Quality evaluation requirements1 ScopeThis document specifies the quality evaluation requirements, test methods, labels and instructions, packages of the new coronavirus IgG antibody detection kit Loading, transportation and storage. This document is suitable for the use of immunochromatography, enzyme-linked immunoassay and chemiluminescence method to detect the new type of coronavirus in human serum, plasma and whole blood. A kit for in vitro qualitative detection of virus-specific IgG antibodies.2 Normative referencesThe content of the following documents constitutes an indispensable clause of this document through normative references in the text. Among them, dated quotations Only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to This document. GB/T 191 Packaging, storage and transportation pictorial signs GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.In vitro diagnostic reagents for professional use3 Terms and definitionsThere are no terms and definitions that need to be defined in this document.4 Quality evaluation requirements4.1 Physical properties 4.1.1 Appearance The appearance should at least conform to. a) All components of the kit are complete and complete, and there is no leakage of liquid; b) The packaging label is clear and non-wearing. 4.1.2 Film strip width The width of the film strip should not be less than 2.5mm. Note. This clause only applies to immunochromatography. 4.1.3 Liquid moving speed The liquid moving speed should not be lower than 10mm/min. Note. This clause only applies to immunochromatography. 4.2 Performance 4.2.1 Compliance rate of positive reference products When using a national positive reference product or a standardized positive reference product for testing, the results should meet the following requirements. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of GB/T 40983-2021_English be delivered?Answer: Upon your order, we will start to translate GB/T 40983-2021_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of GB/T 40983-2021_English with my colleagues?Answer: Yes. The purchased PDF of GB/T 40983-2021_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. 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