YY/T 1176-2010: Cancer antigen CA 15-3 quantitative detection reagent (kit) - Chemiluminescent immunoassay

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Scope

This standard specifies the classification, requirements, test method, identification, labels,
instructions, packaging, transportation and storage of the cancer antigen CA15-3
quantitative detection reagent (kit) (chemiluminescent immunoassay).
This standard is applicable to test cancer antigen CA15-3 reagent (kit) [hereinafter
referred to as “CA15-3 reagent (kit)”], based on the principles of chemiluminescent
immunoassay. It includes the enzymatic and non-enzymatic chemiluminescent
immunoassay detection reagent (kit) with carriers of microwell plates, tubes, magnetic
particles, micro-beads and plastic-beads.
The Standard is not applicable to.
a) The tumor marker calibrators and tumor marker control materials that are intended
for separate sales.
b) Biochip that uses the principle of chemiluminescent immunoassay.

Basic Data

Standard ID	YY/T 1176-2010 (YY/T1176-2010)
Description (Translated English)	Cancer antigen CA 15-3 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	10,167
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 CA15-3 Quantitative Assay (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 cancer antigen principle CA15-3 reagent (box) [ hereinafter referred to as "CA15-3 reagent (boxes) ]. Including microplates, tubes, magnetic particles, beads and plastic beads 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) by chemiluminescence immunoassay for the principle of bio- chips.