DZ/T 0101.12-1994
Active
YY/T 1964-2025
Pending
Industry standards-Medicine
YY/T 1964-2025 Tacrolimus testing kit
YY/T 1964-2025 Tacrolimus testing kit
Basic Information
Standard Code:
YY/T 1964-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical laboratory equipment
ICS Name:
-
Publish Date:
2025-06-18
Implement Date:
2026-07-01
Pages:
12 pages
Scope
This document specifies the requirements for tacrolimus assay kits, including identification, labeling, and user instructions, as well as packaging, transportation, and storage. It also describes the corresponding testing methods.
This document is applicable to kits used for quantitatively determining the tacrolimus content in human whole blood by chemiluminescent immunoassay, homogeneous enzyme immunoassay, immunoturbidimetry, and liquid chromatography-mass spectrometry.
Development Information
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 191-2025 Graphical symbols marking for handling and storage of packages
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 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 29791.2-2013 In vitro diagnostic medical devices—Information supplied by the manufacturer (labelling)—Part 2:In vitro diagnostic reagents for professional use
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