YY/T 1721-2020: Free thyroxine (FT4) testing kit

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Scope

This Standard specifies the classification, requirements, test methods, labeling,
instructions for use, packaging, transportation and storage of free thyroxine testing kit
(hereinafter referred to as FT4 testing kit).
This Standard applies to immunoassay kits for the in vitro quantitative determination
of free thyroxine (FT4) using enzyme labeling, (electro) chemiluminescence labeling,
(time-resolved) fluorescence labeling, and other methods, using DAS-ELISA or
competition method as the principle.
This Standard does not apply to:
a) Reagents for qualitative or semi-quantitative determination of free human
thyroxine labeled with colloidal gold or other methods (such as test strips,
biochips, etc.);
b) Various radioimmunoassay or immunoradioactive testing kits labeled with
radioisotopes such as 125I;
c) Free thyroxine calibrators and free thyroxine quality controls intended for sale
individually or as part of the FT4 testing kit.

Basic Data

Standard ID	YY/T 1721-2020 (YY/T1721-2020)
Description (Translated English)	Free thyroxine (FT4) testing kit
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Word Count Estimation	7,721
Date of Issue	2020-06-30
Date of Implementation	2021-12-01
Regulation (derived from)	Announcement No. 76 (2020) of the National Medical Products Administration
Issuing agency(ies)	State Drug Administration