This Standard specifies the requirements, test methods, label and instructions for use, packaging, transportation, and storage of allergy-specific IgE detection kit. This Standard is applicable to the kit in the medical laboratory for quantitative/semi-quantitative/qualitative detection of allergy-specific IgE in human serum or plasma using enzyme-linked immunosorbent assay, chemiluminescence, fluorescence immunoassay, colloidal gold method, immunoblotting as the principle (hereinafter known as “kit” for short).
Basic Data
Standard ID
YY/T 1581-2018 (YY/T1581-2018)
Description (Translated English)
Allergy-specific IgE detection kit
Sector / Industry
Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard
C44
Classification of International Standard
11.100
Word Count Estimation
11,191
Date of Issue
2018-02-24
Date of Implementation
2019-03-01
Quoted Standard
GB/T 21415; GB/T 29791.2
Regulation (derived from)
China Food and Drug Administration announced No. 27 of 2018
Issuing agency(ies)
State Food and Drug Administration
Summary
This standard specifies the requirements, test methods, labels and instructions for use of allergen-specific IgE antibody test kits, packaging, transportation, and storage. This standard applies to quantification/semiquantification of allergen-specific IgE antibodies in human serum or plasma by enzyme immunoassay, chemiluminescence, fluorescence immunoassay, colloidal gold, and immunoblotting in medical laboratories. Qualitative detection kit (hereinafter referred to as "kit").
