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YY/T 1890-2023 English PDF

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US$179.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1890-2023: Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic method)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1890-2023	179	Add to Cart	3 days	Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic method)	Valid

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YY/T 1713 YY/T 1709 YY/T 1721 YY/T 1892 YY/T 1882

Basic data

Standard ID: YY/T 1890-2023 (YY/T1890-2023)
Description (Translated English): Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic method)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100.10
Word Count Estimation: 9,937
Date of Issue: 2023-09-05
Date of Implementation: 2024-09-15
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the requirements, test methods, identification, labeling and instructions for use, packaging, transportation and storage of hepatitis B virus surface antigen detection kits (immunochromatographic method). This standard applies to hepatitis B virus surface antigen detection reagents for the qualitative detection of hepatitis B virus surface antigen (hereinafter referred to as HBsAg) in human serum, plasma or whole blood using immunochromatographic methods such as colloidal gold method and latex method. box. This document does not apply to hepatitis B virus surface antigen detection kits using enzyme-linked immunoassay, chemiluminescence immunoassay, time-resolved immunofluorescence and other methodologies.

YY/T 1890-2023: Hepatitis B virus surface antigen (HBsAg) detection kit(Immunochromatographic 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 Pharmaceutical Industry Standards of the People's Republic of China Hepatitis B virus surface antigen detection kit Published on 2023-09-05 Implemented on 2024-09-15 Released by the State Drug Administration

Foreword

This document complies with the provisions of GB/T 1.1-2020 "Standardization Work Guidelines Part 1.Structure and Drafting Rules of Standardization Documents" Drafting. Please note that some content in this document may be subject to patents. The publisher of this document assumes no responsibility for identifying patents. This document is proposed by the National Medical Products 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. China Institute of Food and Drug Control, Beijing Institute of Medical Device Inspection (Beijing Medical Biological Protective Equipment Medical Equipment Inspection Research Center), Guangdong Medical Device Quality Supervision and Inspection Institute, Beijing Wantai Biopharmaceutical Co., Ltd., Zhuhai Livzon Reagent Co., Ltd. Co., Ltd., Yingke Xinchuang (Xiamen) Technology Co., Ltd. The main drafters of this document. Liu Yan, Li Kejian, Zhou Cheng, Liu Yanchun, Pan Xiaofang, Xianyang Ling, Zhou Xin, Qin Rong. Hepatitis B virus surface antigen detection kit

1 Scope

This document specifies the requirements, test methods, identification, labeling and use of hepatitis B virus surface antigen detection kit (immunochromatographic method) Instructions for use, packaging, transportation and storage, etc. This document is applicable to the detection of hepatitis B virus surface in human serum, plasma or whole blood using immunochromatographic methods such as colloidal gold method and latex method. Hepatitis B virus surface antigen detection kit for qualitative detection of antigen (hereinafter referred to as HBsAg). This document does not apply to hepatitis B virus expression using enzyme-linked immunoassay, chemiluminescence immunoassay, time-resolved immunofluorescence, etc. Facial antigen detection kit.

2 Normative reference documents

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, the dated quotations For undated referenced documents, only the version corresponding to that date applies to this document; for undated referenced documents, the latest version (including all amendments) applies to this document. GB/T 191 Packaging, storage and transportation pictorial mark 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.Professional in vitro diagnostic reagents

3 Terms and definitions

The terms and definitions defined in GB/T 29791.1 apply to this document.

4 requirements

4.1 Physical inspection 4.1.1 Appearance The appearance of the kit should be neat, the text and labels should be clear, and the liquid components should be clear. 4.1.2 Membrane strip width The width of the membrane strip should be no less than 2.5mm. 4.1.3 Liquid migration speed The liquid migration speed should not be less than 10mm/min. 4.2 Compliance rate of negative reference products Twenty copies of HBsAg national negative reference materials were used for testing, and the results were all negative, and the compliance rate of the negative reference materials was 100%. or use sutra mark ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1890-2023_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1890-2023_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 YY/T 1890-2023_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1890-2023_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. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countries

Question 4: Do you accept my currency other than USD?

Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.