YY/T 1236-2014 English PDFUS$189.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1236-2014: Cytomegalovirus (CMV) IgG/IgM antibody detection kit Status: Valid
Basic dataStandard ID: YY/T 1236-2014 (YY/T1236-2014)Description (Translated English): Cytomegalovirus (CMV) IgG/IgM antibody detection kit Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Classification of International Standard: 11.100 Word Count Estimation: 8,889 Date of Issue: 6/17/2014 Date of Implementation: 7/1/2015 Quoted Standard: YY/T 0466.1 Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30 Issuing agency(ies): State Food and Drug Administration Summary: This Standard applies to the qualitative detection of human serum/plasma CMV IgG/IgM antibody detection reagent (box) (enzyme-linked immunosorbent assay), cytomegalovirus IgG/IgM antibody detection reagent (box) (chemiluminescence), cytomegalovirus virus YY/T 1236-2014: Cytomegalovirus (CMV) IgG/IgM antibody detection kit---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.Cytomegalovirus (CMV) IgG/IgM antibody detection kit ICS 11.100 C44 People's Republic of China pharmaceutical industry standards CMV IgG/IgM antibody detection reagent (box) Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released ForewordThis standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this document may involve patents. Distribution of this document Institutions do not assume the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This standard was drafted. Chinese Academy of Food and Drug test. The main drafters of this standard. Huang Jie, Qu defensive side, the first noble. CMV IgG/IgM antibody detection reagent (box)1 ScopeThis standard specifies the CMV IgG/IgM antibody detection reagent (box) [hereinafter referred to as "reagent (kit)"] requirements, test methods, Logos, labels and brochures, packaging, transportation and storage. This standard applies to the qualitative detection of human serum/plasma CMV IgG/IgM antibody detection reagent (box) (enzyme-linked immunosorbent assay), CMV IgG/IgM antibody detection reagent (box) (chemiluminescence), cytomegalovirus IgG/IgM antibody detection reagent (box) (immunity Fluorescence), cytomegalovirus IgG/IgM antibody detection reagent (box) (Western blot) and the like.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements3 Requirements3.1 CMV IgG antibody detection reagent (box) Technical Requirements 3.1.1 Appearance Appearance should meet the following conditions. a) reagent (box) shall comply with the requirements specified by the manufacturer appearance; b) reagent (box) should complete component packaging clean appearance, no leaks, no damage; signs, labels legible. 3.1.2 Accuracy (positive coincidence rate) With cytomegalovirus IgG antibody test positive reference to national products or through standardized corporate positive reference material for testing, the results should be Meet the requirements. 3.1.3 specificity (negative coincidence rate) With cytomegalovirus IgG antibody test negative national standardized reference materials or by negative reference material for testing, the results should be consistent Claim. 3.1.4 repeatability (precision) 3.1.4.1 with cytomegalovirus IgG antibody detection reagent for detecting repetitive reference material, within run precision coefficient of variation (CV) should not At 15.0%. NOTE. 3.1.4.1 does not apply to products immunoblotting. 3.1.4.2 with cytomegalovirus IgG antibody test repeatability reference material for testing, the result should be a uniform color, and are positive. 3.1.5 limit of detection With cytomegalovirus IgG antibody detection reagent for the national minimum detection limit of the reference product or standardized by the minimum detection limit of the reference material were seized ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1236-2014_English be delivered?Answer: Upon your order, we will start to translate YY/T 1236-2014_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 1236-2014_English with my colleagues?Answer: Yes. 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