YY/T 1482-2016 in English

VALID

Anti-herpes-simplex-virus IgG antibody detection reageant(kit)

Issued on:2016-07-29
Implemented on:2017-06-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $160.00
$156.00

Standard No:	YY/T 1482-2016
Document status:	VALID
Title in English:	Anti-herpes-simplex-virus IgG antibody detection reageant(kit)
Title in Chinese:	单纯疱疹病毒IgG抗体检测试剂（盒）
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2016-07-29
Implemented on:	2017-06-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	anti-herpes-simplex-virus igg antibody detection reageant igg antibodies igg detection introductionthis standard
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本标准规定了单纯疱疹病毒IgG抗体检测试剂（盒）的技术要求、试验方法、标识、标签和说明书、包装、运输和贮存等。本标准适用于定性检测人体血清/血浆中单纯疱疹病毒1型IgG抗体检测试剂（盒）、单纯疱疹病毒2型IgG抗体检测试剂（盒）、单纯疱疹病毒1+2型IgG抗体检测试剂（盒），方法学为酶联免疫法、化学发光法、免疫荧光法、免疫印迹法等。

Introduction

This standard provides specifications for the detection of IgG antibodies against herpes simplex virus. It outlines the requirements for the performance, safety, and labeling of diagnostic reagents. The document includes details on the methods of testing, the expected results, and the conditions under which the tests should be conducted. It also covers the necessary information that must be included on the product label and in the instructions for use. The standard ensures consistency in the production and application of such diagnostic tools. It defines the criteria for the accuracy, reliability, and stability of the test results. Additionally, it addresses the storage and handling conditions to maintain the integrity of the reagents. This standard is intended for use by manufacturers, regulatory authorities, and healthcare professionals.

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

More samples: JC/T 2453-2018 DL/T 368-2010 DL/T 5154-2012

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