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Detection kit for analysis of HER2 gene abnormalities(fluorescent in situ hybridization)
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Basic data
| Standard ID | YY/T 1261-2015 (YY/T1261-2015) |
| Description (Translated English) | Detection kit for analysis of HER2 gene abnormalities(fluorescent in situ hybridization) |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 8,871 |
| Date of Issue | 2015-03-02 |
| Date of Implementation | 2016-01-01 |
| Quoted Standard | GB/T 191; YY/T 0466.1 |
| Regulation (derived from) | The State Food and Drug Administration Announcement 2015 No. 8 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This Standard specifies the gene detection kit (fluorescence in situ hybridization) is defined as HER2, requirements, test methods, marking, labeling, instructions, packaging, transport and storage. This Standard applies to the HER2 gene locus and chromosome 17 centromere fluorescence in situ hybridization probe and counterstain composition, by detecting the sample (usually breast cancer tissue sections) anomalies on the HER2 gene locus and thus aid Analyzing the HER2 gene-related tumors (such as: breast cancer, etc.) and to guide clinical medication kit during treatment. |
YY/T 1261-2015: Detection kit for analysis of HER2 gene abnormalities(fluorescent in situ hybridization)
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Detection kit for analysis of HER2 gene abnormalities (fluorescent in situ hybridization)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
HER2 gene detection kit (fluorescence in situ hybridization)
Issued on. 2015-03-02
2016-01-01 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. Release mechanism of the present document does not assume responsibility for the identification of 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 Ying, Shen Shu, Li Lili, Liu Yan, the first noble.
HER2 gene detection kit (fluorescence in situ hybridization)
1 Scope
This standard specifies the gene detection kit (fluorescence in situ hybridization) definition of HER2, requirements, test methods, marking, labeling, use
Brochures, packaging, transport and storage.
This standard applies to the HER2 gene locus and chromosome 17 centromere fluorescence in situ hybridization probe and counterstain composed by check
Test sample (usually breast cancer tissue sections) anomalies on the HER2 gene locus, which is determined with the HER2 gene related auxiliary swelling
Tumors (such as. breast cancer, etc.) and to guide clinical medication kit during treatment.
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
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Fluorescence in situ hybridization fluorescentinsituhybridization; FISH
According to the principle of complementary base pairing with the target nucleic acid fragment DNA pairing (probe) on the labeling fluorescent dye, and the probe is to be tested
Nucleic acid fragments corresponding materials under certain conditions specific binding (hybridizing) to form a double-stranded nucleic acid, fluorescence microscopy and recorded by means of shape
A type of hybrid duplexes, the number, the sample to be tested to determine whether or not the normal method for detecting target DNA.
3.2
HER2 gene detection kit (fluorescence in situ hybridization) detectionkitforanalysisofHER2geneabnormalities
(Fluorescentinsituhybridization)
And the HER2 gene locus on chromosome 17 centromere-specific fluorescence in situ hybridization probes (hereinafter referred to as. Probe) and re-stain and
Other necessary auxiliary agents composed of a sample by detecting anomalies HER2 gene locus, for assisting judgment and HER2 gene
Related tumors (such as. breast cancer, etc.) and to guide clinical medication kit during treatment (hereinafter. the kit).
4 Requirements
4.1 Appearance
The kit packaging should be complete, no damage, marked complete, clear; each liquid reagent should be clearly labeled, leak-free, color should be consistent with the manufacturer
The provisions of solution should be clear, no precipitation or floc.
4.2 fluorescent signal intensity
Probe in peripheral blood (or broth) prepared for lymphocyte breast Photo/rear and cancerous tissue sections hybridized fluorescence microscope
...
