YY/T 1225-2014 English PDF

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YY/T 1225-2014: Diagnostic kit for detection of anti-mycoplasma pneumoniae
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1225-2014	259	Add to Cart	3 days	Diagnostic kit for detection of anti-mycoplasma pneumoniae	Valid

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Basic data

Standard ID: YY/T 1225-2014 (YY/T1225-2014)
Description (Translated English): Diagnostic kit for detection of anti-mycoplasma pneumoniae
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 11,129
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: GB/T 191
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 colloidal gold, enzyme-linked immunosorbent assay statutory human serum, plasma and whole blood in Mycoplasma pneumoniae IgG, IgM antibody detection kit. This Standard specifies the Mycoplasma pneumoniae antibody detection kit pro

YY/T 1225-2014: Diagnostic kit for detection of anti-mycoplasma pneumoniae

---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.
Diagnostic kit for detection of anti-mycoplasma pneumoniae ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Mycoplasma pneumoniae antibody detection kit Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

This 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. Wang Yumei, Liu Yan, Zhangchun Tao, noble first. Mycoplasma pneumoniae antibody detection kit

1 Scope

This standard specifies the Mycoplasma pneumoniae antibody detection kit product classifications, requirements, test methods, inspection rules, marking, labeling, package Loading, transport and storage. This standard applies to colloidal gold, enzyme-linked immunosorbent assay statutory human serum, plasma and whole blood Mycoplasma pneumoniae IgG, IgM antibody The test kit.

2 Normative references

The 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. GB/T 191 Packaging - Pictorial signs Category 3 According to the principle of the method can be divided into different colloidal gold, enzyme-linked immunosorbent assay and the like.

4 Requirements

4.1 Physical examination 4.1.1 Appearance Shall comply with the requirements specified by the manufacturer. 4.1.2 liquid migration speed (only colloidal gold chromatography) Shall comply with the requirements specified by the manufacturer. 4.1.3 film strip width (only colloidal gold chromatography) Shall comply with the requirements specified by the manufacturer. 4.2 specificity (negative reference product compliance rate) Negative reference materials for detecting Mycoplasma pneumoniae antibody test result should be negative. 4.3 accuracy (positive reference product compliance rate) Mycoplasma pneumoniae (including strong, medium and weak positive) reference materials, and the results should be all positive. 4.4 The minimum detection limit In certain minimum detectable concentration limit of reference materials for testing, the result should be positive for the reference product concentration should not exceed 1.64 (complement knot ......

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