T/CSBME 028-2021 Active Group standards

T/CSBME 028-2021 Myocardial troponin I quantification assay reagent (kit) (fluorescent immunochromatographic assay)

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 028-2021

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, testing methods, marking, packaging, transportation, and storage for quantitative determination reagents (kits) of myocardial troponin I (fluorescence immunoassay method). This document is applicable to detecting the content of troponin I in human serum/plasma/whole blood, and is mainly used in clinical auxiliary diagnosis of myocardial infarction. This document is applicable to quantitatively determining troponin I with the fluorescence immunoassay method based on the principle of double antibody sandwich assay. Main technical content: This document specifies the technical requirements, testing methods, marking, packaging, transportation, and storage for quantitative determination reagents (kits) of myocardial troponin I (fluorescence immunoassay method).