YY/T 1163-2009: Total Prostate Specific Antigen (t-PSA) Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay)

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Scope

This Standard specifies the terms and definitions, classification, requirements, test
methods, inspection rules, marks, labels, operating instructions, packaging,
transportation, and storage of total prostate specific antigen (t-PSA) quantitative
detection reagent (kit) (chemiluminescent immunoassay).
This Standard applies to the quantitative detection of total prostate specific antigen
(t-PSA) quantitative detection reagent (kit) (herein after referred to as “t-PSA reagent
(kit)”) of the human blood matrix or other body fluid components based on the
principle of chemiluminescent immunoassay. It includes the enzymatic and
non-enzymatic chemiluminescence immunoassay detection reagent (kit) with carriers
such as microplates, tubes, magnetic particles, microbeads, and plastic beads.
This Standard does not apply to the requirements of the calibrator and quality control
material in reagent kits.

Basic Data

Standard ID	YY/T 1163-2009 (YY/T1163-2009)
Description (Translated English)	Total Prostate Specific Antigen (t-PSA) 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	10,149
Date of Issue	2009-12-30
Date of Implementation	2011-06-01
Quoted Standard	GB/T 21415-2008
Regulation (derived from)	China Food and Drug Administration Announcement 2009 No.83
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the total prostate specific antigen (t-PSA) quantitative assay reagent (box) (chemiluminescent immunoassay) products, terms and definitions, classification, requirements, test methods, inspection rules, marking, labeling, instructions, packaging, transport and storage. This standard applies to the principle of chemiluminescence immunoassay for the quantitative detection of human blood or other body fluid composition matrix of total prostate specific antigen (t-PSA) quantitative assay kit (hereinafter referred to as "t-PSA kit"). 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 the kit calibrators and control materials requirements.