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Human gene in situ hybridization detection kit
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Basic data
| Standard ID | YY/T 1459-2016 (YY/T1459-2016) |
| Description (Translated English) | Human gene in situ hybridization detection kit |
| Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) |
| Classification of Chinese Standard | C44 |
| Classification of International Standard | 11.100 |
| Word Count Estimation | 8,821 |
| Date of Issue | 2016-01-26 |
| Date of Implementation | 2017-01-01 |
| Quoted Standard | GB/T 191; YY/T 0466.1 |
| Regulation (derived from) | China Food and Drug Administration Bulletin 2016 No.25 |
| Issuing agency(ies) | State Food and Drug Administration |
| Summary | This standard specifies the requirements, test methods, instructions, labels, labels, and packaging, transportation, and storage of human genetic in situ hybridization kits. This standard applies to in situ hybridization detection kits for human gene amplification, recombination, deletion, etc., and generally includes fluorescence in situ hybridization kits and in situ hybridization kits. This standard does not apply to: a) in situ hybridization kits for detection of non-human genes (eg viruses, bacteria, etc.); b) in combination with other detection methods (eg PCR, flow cytometry, etc.) using hybridization assay kits The |
YY/T 1459-2016: Human gene in situ hybridization 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.
Human gene in situ hybridization detection kit
ICS 11.100
C44
People's Republic of China Pharmaceutical Industry Standard
Human gene in situ hybridization assay kit
2016-01-26 release
2017-01-01 Implementation
State Food and Drug Administration issued
Foreword
This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The release of this document
The Agency does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized.
This standard is drafted by the China Food and Drug Administration Research Institute.
The main drafters of this standard. Liu Yan, Wang Yumei, Huang Jie, Sun Nan, Gao Shangxian
Human gene in situ hybridization assay kit
1 Scope
This standard specifies the requirements, test methods, instructions, logos, labels, and packages for human genetic in situ hybridization kits.
Equipment, transportation, storage.
This standard is applicable to in situ hybridization detection kits for human gene amplification, recombination, deletion, etc., and generally includes fluorescence in situ hybrid
Delivery kit and in situ hybridization kit.
This standard does not apply to.
a) in situ hybridization detection kits for non-human genes (eg, viruses, bacteria, etc.)
b) Use a hybridization assay kit in combination with other detection methods such as PCR, flow cytometry, and the like.
2 normative reference documents
The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article
Pieces. For undated references, the latest edition (including all modifications) applies to this document.
GB/T 191 packaging and storage icon
YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements
3 terms and definitions
The following terms and definitions apply to this document.
3.1
In situ hybridization insituhybridization, ISH
According to the principle of base complementary pairing, the dye is labeled on a nucleic acid fragment (probe) paired with the target DNA, which is linked to the material to be examined
The corresponding nucleic acid fragments were specifically bound (hybridized) under certain conditions to form double-stranded nucleic acids, which were observed and recorded by microscopy to form hybrid double
Chain type, quantity, and thus determine the sample to be tested in the target DNA normal or not detection method.
4 requirements
4.1 appearance
Production enterprises should be based on their own product packaging characteristics of the appropriate appearance requirements. Generally should be the composition of the components of the kit, traits;
Packaging, labeling and other requirements.
4.2 Signal strength
The probe was crossed with a photograph or positive tissue section made of peripheral blood (or its culture medium) lymphocytes, and under the microscope,
A signal that can be visually recognized.
4.3 probe quality judgment
Fluorescence in situ hybridization kit in peripheral blood (or its culture medium) Lymphocytes were made in a photograph that was in the medium phase of the phase
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