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YY/T 1193-2011 (YYT 1193-2011)

Chinese standards (related to): 'YY/T 1193-2011'
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YY/T 1193-2011English105 Add to Cart 0--10 minutes. Auto immediate delivery. Follicle stimulating hormone (FSH) quantitative immunoassay kit (chemiluminescent immunoassay) YY/T 1193-2011 Valid YYT 1193-2011

Standard ID YY/T 1193-2011 (YY/T1193-2011)
Description (Translated English) Follicle stimulating hormone (FSH) quantitative immunoassay 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 9,976
Date of Issue 2011-12-31
Date of Implementation 2013-06-01
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 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall)
Proposing organization State Food and Drug Administration
Issuing agency(ies) China Food and Drug Administration
Summary This standard specifies the follicle stimulating hormone (FSH) quantitative assay (box) (chemiluminescent immunoassay) classification, requirements, test methods, marking, labeling, instructions, packaging, transportation and storage. This standard applies to the principle of chemiluminescence immunoassay for the quantitative detection of human blood or other body fluids matrix components of follicle stimulating hormone (FSH) quantitative assay (box) [The following tube called "FSH 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 for individual sales people follicle stimulating hormone calibrators and control materials follicle stimulating hormone, b) to chemiluminescent immunoassay for the principle of bio-chips.