YY/T 1581-2018 in English

VALID

Allergy-specific IgE detection kit

Issued on:2018-02-24
Implemented on:2019-03-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $140.00
$136.00

Standard No:	YY/T 1581-2018
Document status:	VALID
Title in English:	Allergy-specific IgE detection kit
Title in Chinese:	过敏原特异性IgE抗体检测试剂盒
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-02-24
Implemented on:	2019-03-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	allergy-specific ige detection kit introductionthis standard allergen-specific ige antibody detection kits specific ige antibodies ige detection
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本标准规定了过敏原特异性IgE抗体检测试剂盒的要求、试验方法、标签和使用说明书、包装、运输和贮存。
本标准适用于在医学实验室以酶联免疫法、化学发光法、荧光免疫法、胶体金法、免疫印迹法为原理对人血清或血浆中的过敏原特异性IgE抗体进行定量/半定量/定性检测的试剂盒。

Introduction

This standard provides detailed specifications for the performance, safety, and labeling requirements of diagnostic kits used to detect specific IgE antibodies related to allergens. It outlines the necessary procedures for the validation and verification of these kits, ensuring accurate and reliable results in clinical settings. The standard covers aspects such as analytical sensitivity, specificity, and repeatability, which are essential for the proper functioning of the test kits. It also includes guidelines for the storage, transportation, and handling of the kits to maintain their integrity and effectiveness. Additionally, the standard addresses the requirements for the packaging and labeling of the kits, ensuring that users receive clear and comprehensive information about the product's intended use, limitations, and proper application. The content is structured to support manufacturers, healthcare professionals, and regulatory bodies in ensuring the quality and consistency of allergen-specific IgE antibody detection kits.

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

More samples: NB/T 47013.2-2015 QC/T 942-2021 DL/T 5154-2012

Sample only — not a preview of YY/T 1581-2018

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