This standard specifies the requirements, test methods, labels and instructions for use, packaging, transportation and storage of prolactin quantitative labeling immunoassay kits. This standard applies to kits for the quantitative determination of prolactin based on the double-antibody sandwich method. This standard does not apply to reagents for the semi-quantitative determination of prolactin (such as test strips, etc.) labeled with colloidal gold or other methods; various prolactin radioimmunoassay or immunoradiological kits labeled with Class I radioactive isotopes.
YY/T 1516-2017 Referenced Document
GB/T 191-2008 Packaging.Pictorial marking for handling of goods
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