T/CSBME 027-2021 Active Group standards

T/CSBME 027-2021 Creatine Kinase MB Isoenzyme Quantitative Assay Reagent Kit (Fluorescent Immunoassay)

Publish Date: 2021-01-16 Implement Date: 2021-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/CSBME 027-2021

Standard Type: Group standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Diagnostic equipment

Publish Date: 2021-01-16

Implement Date: 2021-03-01

Scope

Scope: This document specifies the technical requirements, test methods, labeled packaging, transportation, and storage for creatine kinase isoenzyme (CKMB) quantitative determination reagents (kits) using fluorescence immunoassay. This document is applicable to the determination of creatine kinase isoenzyme (CKMB) content in human serum, plasma, or whole blood. This document is applicable to reagents for quantitative determination of creatine kinase isoenzyme (CKMB) using fluorescence immunoassay based on the principle of double antibody sandwich assay. Main technical content: This document specifies the technical requirements, test methods, labeled packaging, transportation, and storage for creatine kinase isoenzyme (CKMB) quantitative determination reagents (kits) using fluorescence immunoassay.