YY/T 1589-2018 in English

VALID

Estradiol testing kit(Chemiluminescent immunoassay)

Issued on:2018-04-11
Implemented on:2019-05-01
File Format:PDF
Delivery:Via email within 1~3 business days

Price(USD)： $100.00
$97.00

Standard No:	YY/T 1589-2018
Document status:	VALID
Title in English:	Estradiol testing kit(Chemiluminescent immunoassay)
Title in Chinese:	雌二醇测定试剂盒（化学发光免疫分析法）
Language:	English
File Format:	Electronic (PDF)
Delivery:	Via email within 1~3 business days
Issued on:	2018-04-11
Implemented on:	2019-05-01
ICS Classification:	11.100-Laboratory medicine
Chinese Classification:	C44-Medical laboratory equipment
Professional Classification:	YY-Pharmaceutics
Related Keywords:	chemiluminescent immunoassay reagent kit chemiluminescent immunoassay kit
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本标准规定了雌二醇测定试剂盒（化学发光免疫分析法）的要求、试验方法、标签和使用说明书、包装、运输和贮存等要求。
本标准适用于以化学发光免疫分析为原理测定雌二醇的试剂盒，包括以微孔板、管、磁微粒、微珠和塑料珠等为载体的化学发光免疫分析测定试剂盒。

Introduction

This standard provides specifications for a reagent kit used in the determination of estradiol through chemiluminescent immunoassay. It outlines the requirements for the composition, performance, and validation of the kit, ensuring consistency and reliability in analytical procedures. The document includes details on the preparation and handling of samples, as well as the operational parameters necessary for accurate measurement. Additionally, it defines the criteria for assessing the precision, accuracy, and stability of the reagent kit. The standard also covers the documentation and labeling requirements to ensure proper use and traceability. It serves as a reference for manufacturers, laboratories, and regulatory authorities in the development and application of such reagent kits.

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

More samples: DL/T 368-2010 QC/T 942-2021 JJG 21-2008

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