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YY/T 1163-2009 (YYT 1163-2009)

Chinese standards (related to): 'YY/T 1163-2009'
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YY/T 1163-2009English135 Add to Cart 0--10 minutes. Auto immediate delivery. Total Prostate Specific Antigen (t-PSA) Quantitative Detection Reagent (Kit) (Chemiluminescent Immunoassay) YY/T 1163-2009 Valid YYT 1163-2009

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 & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C44
Classification of International Standard 11.100
Word Count Estimation 10,151
Date of Issue 2009-12-30
Date of Implementation 2011-06-01
Quoted Standard GB/T 21415-2008
Drafting Organization Beijing Medical Device Testing
Administrative Organization National Standardization Technical Committee of Medical clinical testing laboratories and in vitro diagnostic systems
Regulation (derived from) China Food & Drug Administration Announcement 2009 No.83
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.