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YY/T 1178-2010 (YYT 1178-2010)

Chinese standards (related to): 'YY/T 1178-2010'
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YY/T 1178-2010English145 Add to Cart 0--10 minutes. Auto immediate delivery. Carbohydrate antigen CA19-9 quantitative detection reagent(kit) - Chemiluminescent immunoassay YY/T 1178-2010 Valid YYT 1178-2010

Standard ID YY/T 1178-2010 (YY/T1178-2010)
Description (Translated English) Carbohydrate antigen CA19-9 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 10,177
Date of Issue 2010-12-27
Date of Implementation 2012-06-01
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) State Food and Drug Administration Notice 2010 No. 97
Proposing organization National laboratories and in vitro diagnostic medical systems Clinical Laboratory Standardization Technical Committee (SAC/TC 136)
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the carbohydrate antigen CA19-9 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 the principle carbohydrate antigen (CA19-9) 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.