T/GDMDMA 0027-2023 N-terminal propeptide of type III collagen assay kit (chemiluminescent immunoassay)
T/GDMDMA 0027-2023 N-terminal propeptide of type III collagen assay kit (chemiluminescent immunoassay)
Basic Information
Scope
This document specifies the requirements, test methods, labels and user manuals, packaging, transportation, and storage for the Type III procollagen N-terminal peptide assay kit (chemiluminescence immunoassay) (hereinafter referred to as the PIII NP kit). This document applies to kits that use chemiluminescence immunoassay as the principle for quantitatively determining the content of Type III procollagen N-terminal peptide in human blood, including enzymatic and non-enzymatic chemiluminescence immunoassay kits with microplates, tubes, magnetic particles, etc. as carriers, including manual operation methods and instrument-automated operation methods. This document does not apply to Type III procollagen N-terminal peptide calibrators and Type III procollagen N-terminal peptide quality control products intended for separate sale.