YY/T 1459-2016 English PDFUS$159.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1459-2016: Human gene in situ hybridization detection kit Status: Valid
Basic dataStandard 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: 8,894 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 ForewordThis 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 kit1 ScopeThis 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 documentsThe 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 requirements3 terms and definitionsThe 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 requirements4.1 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 ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1459-2016_English be delivered?Answer: Upon your order, we will start to translate YY/T 1459-2016_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 1459-2016_English with my colleagues?Answer: Yes. 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