T/CSBME 026-2021 Active Group standards

T/CSBME 026-2021 Muscle Myoglobin Quantitative Detection 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 026-2021

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, markings, packaging, transportation, and storage for myoglobin quantitative determination reagents (kits) (fluorescence immunoassay). This document is applicable to detecting myoglobin levels in human serum/plasma/whole blood, and is primarily used in clinical settings for assisting in the diagnosis of myocardial infarction. This document is applicable to reagents for quantitatively determining myoglobin using the fluorescence immunoassay method based on the principle of a double-antibody sandwich assay. Main technical content: This document specifies the technical requirements, test methods, markings, packaging, transportation, and storage for myoglobin quantitative determination reagents (kits) (fluorescence immunoassay).