YY/T 1605-2018 in English

VALID

Hemoglobin Alc testing kit(latex immunoturbidimetric method)

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

Price(USD)： $120.00
$117.00

Standard No:	YY/T 1605-2018
Document status:	VALID
Title in English:	Hemoglobin Alc testing kit(latex immunoturbidimetric method)
Title in Chinese:	糖化血红蛋白测定试剂盒（胶乳免疫比浊法）
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:	latex immunoturbidimetric method hemoglobin alc latex immunoturbidimetry hemoglobin latex
Related Topics:	mass spectrometry immunoassay Protein Assay Kit Serum apolipoprotein a1 and apolipoprotein b immunoturbidimetric assay Glycosylated hemoglobin h8 ny/t 1605 rapid box assay protein gelation Infrared rationing non-glycosylated hemoglobin protein colorimetry specific infrared Turbidity of white sugar How to Measure Protein Glycosylation Glycated hemoglobin gold Common types of glycosylated hemoglobin Protein Assay Kit Two reagents for turbidimetry non-collagenous glycoprotein rapid glycated hemoglobin collagen glycoprotein blood kit Collagen Kit Glycoprotein chain collagen glycoprotein Non-collagen Glycoprotein+ Collagen Cardiovascular portable glycated hemoglobin Determination of Beverage Protein by Far Infrared Total Sugar Determination Kit Glycosylated hemoglobin + gold Hemoglobin determination Hemoglobin Glycosylated hemoglobin fast Glycosylated protein staining Immunoturbidimetry Glycated hemoglobin gold Turbidity of white sugar Blood typing reagents Blood typing reagents protein assay How are proteins glycosylated Glycated hemoglobin gold Type Collagen Kit Hemoglobin reagent p3 glycosylated hemoglobin Immunoturbidimetry 14 protein assay how protein glycosylation caramel blood red Glycosylated hemoglobin 95 box protein sugar immunity Collagen Autoimmunity How much hemoglobin is measured Glycosylated hemoglobin fast Immunoturbidimetric detection reagent (box) Glycosylated hemoglobin test system History of latex immunoturbidimetry The difference between immunoturbidimetry and scattering turbidimetry Immunoturbidimetric instrument Lactopeptone medium The role of hemagglutinin glycoprotein ATP kit usage protein glycosylation channel Glycolysis/OXPHOS Assay Kit OD600 infrared turbidity Vaccine protein glue protein glycosylation process Glycated blood high pressure liquefaction Whole blood lactate 3.96 High performance liquid chromatography for detection of glycosylated hemoglobin Proteoglycan Liquid Phase Method Glycated hemoglobin and glycated albumin detection methods Classification and principles of blood glucose testing methods Collagen kit detection method Various immunological methods for glycated hemoglobin determination Comparison of commonly used protein concentration determination methods Hemoglobin reagent industry Glycated hemoglobin measurement method and principle Immune turbidimetry industry Glycated serum protein test method Test kit (latex method) industry Glycated hemoglobin detection methods and principles Surface glycoprotein determination method Methodological study on glycated albumin Glycated hemoglobin chromatography method Urine free hemoglobin determination method Glycated hemoglobin test strip technology Glycated hemoglobin methodological differences Protein emulsion stability test method Preparation method of catalyst for protein digestion Methods for removing protein from polysaccharides Albumin colorimetric detection method Method for determination of glycated hemoglobin in rats Glycated hemoglobin detection methodology Comparison of protein detection methods Comparison of protein detection methods Fibrin formation determination methodTurbidimetric method yy/t1630-2018 Comparison of protein concentration detection methods Protein gel purification method Glycated hemoglobin methodology Comparison of protein purification methods Methods for identification of glycosylated proteins Methods for protein deglycosylation Bio-Rad HbA1c Methodology yy/t1615-2018 Glycated hemoglobin detection method

本标准规定了糖化血红蛋白测定试剂盒（胶乳免疫比浊法）的要求、试验方法、标识、标签、使用说明书、包装、运输和贮存等要求。
本标准适用于采用胶乳免疫比浊法对人全血中的糖化血红蛋白进行定量检测的试剂盒，包括在半自动、全自动生化分析仪、免疫分析仪上使用的试剂盒。

Introduction

This document specifies the requirements for the performance, safety, and labeling of reagent kits used in the determination of glycated hemoglobin by latex immunoturbidimetry. It covers aspects such as analytical sensitivity, specificity, precision, and accuracy. The standard also outlines the necessary conditions for storage, stability, and shelf life of the reagent kits. Additionally, it provides guidelines for the manufacturer's instructions for use, packaging, and quality control procedures. The document is intended to ensure consistency and reliability in the measurement results obtained using these reagent kits, facilitating their application in clinical diagnostics. It includes test methods for evaluating the performance characteristics of the kits and defines the requirements for validation and verification processes. The standard is applicable to manufacturers, users, and regulatory authorities involved in the development, production, and use of such reagent kits.

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

More samples: DL/T 368-2010 JGJ 94-2008 DL/T 5154-2012

Sample only — not a preview of YY/T 1605-2018

Loading PDF document...

Error loading PDF. Please make sure the file is valid and try again.

We also recommend

YY/T 0688.2-2024 in English

Clinical laboratory testing and in vitro diagnostic systems - Performance evaluation of equipment for infectious pathogen susceptibility testing and antimicrobial susceptibility testing - Part 2: Performance evaluation of equipment for antimicrobial susce
2024-09-29
YY/T 1916-2023 in English

Interleukin-6(IL-6) testing kit(labelling immunoassay)
2023-09-05
YY/T 0032-2004 in English

Haemglobin instrument
2004-11-08
YY/T 1793-2021 in English

Bacterial endotoxin detection kit
2021-09-06
YY/T 1709-2020 in English

Evaluation of measurement uncertainty of calibrators for in vitro diagnostic kits
2020-06-30