YY/T 1183-2024 Active Industry standards-Medicine

YY/T 1183-2024 Detection reagent kit for enzyme-linked immunoabsorbent assay

YY/T 1183-2024 Detection reagent kit for enzyme-linked immunoabsorbent assay

Publish Date: 2024-09-29 Implement Date: 2025-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1183-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical laboratory equipment

ICS Name: -

Publish Date: 2024-09-29

Implement Date: 2025-10-15

Pages: 16 pages

Scope

This document specifies the requirements, marking, labeling, and usage instructions for enzyme-linked immunosorbent assay (ELISA) test kits, as well as their packaging, transportation, and storage. It also describes the corresponding testing methods.
This document applies to quantitative or qualitative detection kits (hereinafter referred to as "test kits") that use ELISA as the principle for testing in medical laboratories.

Development Information

Word Count: 18 Thousand words Pages: 16 pages

Replace the following standards

YY/T 1183-2010 Detection reagent(kit) for enzyme-linked immunoabsorbent assay(ELISA)

Referenced Standards

GB/T 191-2000 Packaging—Pictorial marking for handling of goods GB/T 191-2008 Packaging—Pictorial marking for handling of goods GB/T 21415-2008 In vitro diagnostic medical devices—Measurement of quantities in biological samples—Metrological traceability of values assigned to calibrators and control materials GB/T 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use GB/T 21415-2025 In vitro diagnostic medical devices—Requirements for establishing metrological traceability of values assigned to calibrators,trueness control materials and human samples GB/T 191-2025 Graphical symbols marking for handling and storage of packages

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