YY/T 1611-2018 in English

VALID

Human immunodeficiency virus antibodies detection kits(Immuno-chromatography)

Issued on:2018-12-20
Implemented on:2020-01-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $110.00
$107.00

Standard No:	YY/T 1611-2018
Document status:	VALID
Title in English:	Human immunodeficiency virus antibodies detection kits(Immuno-chromatography)
Title in Chinese:	人类免疫缺陷病毒抗体检测试剂盒（免疫层析法）
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-12-20
Implemented on:	2020-01-01
ICS Classification:	11.040.30-Surgical instruments and materials
Chinese Classification:	C30-Medical apparatus and devices in general
Professional Classification:	YY-Pharmaceutics
Related Keywords:	human immunodeficiency virus antibodies detection kits human immunodeficiency virus antibody detection kits human virus immunodeficiency
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本标准规定了人类免疫缺陷病毒抗体检测试剂盒（免疫层析法）的要求、试验方法、标识、标签、使用说明书、包装、运输和贮存。本标准适用于以免疫层析法为原理，对人血清或血浆中的人类免疫缺陷病毒(human immunodeficiency virus,HIV)1型和2型（HIV-1/2）抗体进行定性检测的胶体金法、胶体硒法、免疫层析法、乳胶层析法等人类免疫缺陷病毒抗体检测试剂盒。

Introduction

This standard provides specifications for the performance and quality requirements of human immunodeficiency virus antibody detection kits using immunochromatographic methods. It outlines the necessary procedures for testing, including sensitivity, specificity, and accuracy. The document also includes guidelines for the preparation and handling of samples, as well as the validation of test results. Additionally, it defines the conditions under which the test should be conducted to ensure reliable outcomes. The standard covers aspects such as packaging, labeling, and storage requirements to ensure the product meets safety and effectiveness criteria. It serves as a reference for manufacturers, regulatory authorities, and users to ensure consistency and reliability in the application of such diagnostic tools.

*** Please note: This description may not be accurate, please refer to the official documentation.

More samples: GB 50021-2001(2009) JC/T 2453-2018 DL/T 5154-2012

Sample only — not a preview of YY/T 1611-2018

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