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YY/T 1786-2024: Hepatitis B e antigen (HBeAg) detection kit(chemiluminescent immunoassay)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1786-2024 | English | 289 |
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Hepatitis B e antigen (HBeAg) detection kit(chemiluminescent immunoassay)
| Valid |
YY/T 1786-2024
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Basic data | Standard ID | YY/T 1786-2024 (YY/T1786-2024) | | Description (Translated English) | Hepatitis B e antigen (HBeAg) detection kit(chemiluminescent immunoassay) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100.10 | | Word Count Estimation | 14,125 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2025-07-20 | | Issuing agency(ies) | State Drug Administration | YY/T 1786-2024: Hepatitis B e antigen (HBeAg) detection kit(chemiluminescent immunoassay)---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 e antigen detection kit
(Chemiluminescent Immunoassay)
Released on 2024-07-08
2025-07-20 Implementation
The State Drug Administration issued
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 for standardization documents"
Drafting.
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Medical Clinical Testing Laboratories and In Vitro Diagnostic Systems (SAC/TC136).
This document was drafted by. China Food and Drug Inspection Institute, Abbott Trading (Shanghai) Co., Ltd., Zhengzhou Antu Bioengineering Co., Ltd.
Co., Ltd., Guangzhou Darui Biotechnology Co., Ltd., Beijing Wantai Biopharmaceutical Co., Ltd., Kemei Diagnostics Technology Co., Ltd.
company.
The main drafters of this document are. Li Kejian, Zhou Cheng, Wang Xuefeng, Zhang Lihong, Wu Yingsong, Wang Honglan and Wang Jianmei.
Hepatitis B virus e antigen detection kit
(Chemiluminescent Immunoassay)
1 Scope
This document specifies the technical requirements, identification, labeling, use, and
The instructions, packaging, transportation and storage, etc. describe the corresponding test methods.
This document applies to the kit for determining hepatitis B virus e antigen in human serum and plasma using chemiluminescent immunoassay technology (with
The kit includes chemiluminescence, microparticle chemiluminescence, electrochemiluminescence, photoluminescence and time-resolved fluorescence.
method.
This document does not apply to.
a) Hepatitis B virus e antigen calibrators and hepatitis B virus e antigen quality controls intended for separate sale;
b) Biochip based on chemiluminescent immunoassay principle.
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 191 Pictorial markings for packaging, storage and transportation
GB/T 21415-2008 Metrology for the measurement of quantities in biological samples for in vitro diagnostic medical devices - Calibrators and control materials
Traceability
GB/T 29791.2 Information provided by the manufacturer of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents
3 Terms and definitions
There are no terms or definitions that require definition in this document.
4 Requirements
4.1 Quantitative detection kit
4.1.1 Appearance
The following requirements should be met.
a) All components of the kit should be complete and intact, with no liquid leakage;
b) The Chinese packaging label should be clear and undamaged.
4.1.2 Traceability
Manufacturers should provide the source, value assignment method and uncertainty of the calibration materials used in accordance with GB/T 21415-2008 and relevant regulations.
content.
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