YY/T 1161-2009: Translated English of Chinese Standard. (YYT 1161-2009, YY/T1161-2009, YYT1161-2009): Tumor Associated Antigen CA125 Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)

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https://www.chinesestandard.net, 2014 M12 8 - 13 pages
This standard specifies the terms and definitions, classification, requirements, test methods, inspection rules, identification, labels, instructions, packaging, transportation and storage of tumor associated antigen CA125 quantitative determination reagent (kit) (chemiluminescence immunoassay). This standard is applicable to quantitative detection of tumor associated antigen (CA125) reagent (kit), based on the principles of chemiluminescence immunoassay. It includes the enzymatic and non-enzymatic chemiluminescence immunoassay detection reagent (kit) with carriers of micro-plates, tubes, magnetic particles, micro-beads and plastic beads. This standard is not applicable to the requirements of calibrators and quality control products in the kit.
 

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Contents

Foreword
3
Scope
4
Classification
6
Test methods
7
Inspection rules of products
9
Marks labels and instructions
11
Packaging transportation and storage
12
Bibliography
13

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