YY/T 1177-2010: Cancer antigen CA72-4 quantitative detection reagent (kit) - Chemiluminescent immunoassay

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Scope

This Standard specifies the classification, requirements, test methods, marking,
labeling, instruction manual, packaging, transportation, and storage of the cancer
antigen CA72-4 quantitative detection reagent (kit) (chemiluminescent immunoassay).
This Standard applies to the quantitative detection of cancer antigen CA72-4 reagent
(kit) [hereinafter referred to as “CA72-4 reagent (kit)”] based on the principle of
chemiluminescent immunoassay. It includes the enzymatic and non-enzymatic
chemiluminescent immunoassay detection reagent (kit) with the carriers such as
microplates, pipes, magnetic particles, microbeads, and plastic beads.
The Standard does not apply to.
a) The tumor marker calibrator and tumor marker quality control materials intended
for separate sales.
b) Biochip in the principle of chemiluminescent immunoassay.

Basic Data

Standard ID	YY/T 1177-2010 (YY/T1177-2010)
Description (Translated English)	Cancer antigen CA72-4 quantitative detection reagent (kit) - Chemiluminescent immunoassay
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C44
Classification of International Standard	11.100
Word Count Estimation	10,190
Date of Issue	2010-12-27
Date of Implementation	2012-06-01
Quoted Standard	GB/T 21415-2008
Regulation (derived from)	State Food and Drug Administration Notice 2010 No. 97
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the cancer antigen CA72-4 quantitative determination reagent (box) (chemiluminescent immunoassay) classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to chemiluminescence immunoassay for the quantitative determination of human carcinoembryonic antigen principle CA72-4 reagent (box). Including microplates, tubes, magnetic particles, beads and plastic beads, etc. as the carrier of enzymatic and non- enzymatic chemiluminescence immunoassay reagent (box). This standard does not apply to: a) intended to be used tumor markers sold separately tumor marker substance calibrators and control products, b) to chemiluminescent immunoassay for the principle of bio- chips.