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YY/T 1161-2009 English PDF (YYT1161-2009)

YY/T 1161-2009 English PDF (YYT1161-2009)

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YY/T 1161-2009: Tumor Associated Antigen CA125 Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)
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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