YY/T 1596-2017 English PDFUS$199.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 1596-2017: Influenza A virus nucleic acid detection kit(fluorescent PCR) Status: Valid
Basic dataStandard ID: YY/T 1596-2017 (YY/T1596-2017)Description (Translated English): Influenza A virus nucleic acid detection kit(fluorescent PCR) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C44 Classification of International Standard: 11.100 Word Count Estimation: 10,180 Date of Issue: 2017-12-05 Date of Implementation: 2018-12-01 Issuing agency(ies): State Food and Drug Administration YY/T 1596-2017: Influenza A virus nucleic acid detection kit(fluorescent PCR)---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.Influenza A virus nucleic acid detection kit (fluorescent PCR) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Influenza A virus nucleic acid test kit (Fluorescent PCR method) 2017-12-05 Published 2018-12-01 implementation State Food and Drug Administration released Directory Foreword Ⅲ 1 Scope 1 2 Normative references 1 3 Terms and definitions 1 4 Requirements 1 5 test methods 2 6 labels and instructions 3 7 Packaging, transportation and storage 3 Reference 4 ForewordThis standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of this document may be patentable. The issuing agencies of this document do not bear the responsibility of identifying these patents. This standard proposed by the State Food and Drug Administration. This standard by the National Medical Clinical Laboratory and in vitro diagnostic system standardization Technical Committee (SAC/TC136) centralized. This standard was drafted unit. China Institute of Food and Drug Control, Shanghai Jiang Biological Technology Co., Ltd., Jiangsu master Biotechnology Co., Ltd., Beijing Huada Ji Bi love Biotechnology Co., Ltd. The main drafters of this standard. Zhouhai Wei, Shi Dawei, Zhu Qinwei, Liu Zhonghua, Liu Cheng, Shen Shu, Zhang Chun Tao. Influenza A virus nucleic acid test kit (Fluorescent PCR method)1 ScopeThis standard specifies the terms and definitions of influenza A nucleic acid detection kit (fluorescence PCR method) (hereinafter referred to as "kit"), to Requirements, test methods, labels and instructions, as well as packaging, shipping and storage. This standard applies to fluorescent PCR method for the principle of qualitative detection of human nasopharyngeal swab or other respiratory secretions samples of influenza A Viral nucleic acid kit. This standard does not apply to the principle of constant temperature amplification, qualitative detection of human nasal, throat swab or other respiratory secretions samples of influenza A Viral nucleic acid kit.2 Normative referencesThe following documents for the application of this document is essential. For dated references, only the dated version applies to this article Pieces. For undated references, the latest edition (including all amendments) applies to this document. GB/T 191 Packaging - Pictorial signs GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (LABEL) SECTION 2. PROFESSIONAL IN VITRO DIAGNOSTIC AGENTS3 Terms and definitionsThe following terms and definitions apply to this document. 3.1 Fluorescent PCR method fluorescencepolymerasechainreaction Also known as real-time fluorescent PCR, the change in fluorescence energy released by the fluorescent dye during PCR directly reflects the PCR amplification yield Fluctuations in volume, fluorescence signal variables and amplification products is proportional to the variable, and through the collection and analysis of fluorescence in order to achieve the original template Line analysis of PCR.4 requirements4.1 appearance The appearance of the product should be consistent. a) kit should meet the appearance requirements of the manufacturer; b) The kit should be complete components, packaging, clean appearance, no leakage, no damage; signs, labels and clear writing. 4.2 positive reference coincidence rate With the national positive reference or the standard positive reference for testing, the results should be consistent with the corresponding reference requirements. The standardized positive reference should meet the following requirements. a) include influenza genotypes of not less than the national positive reference; ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 1596-2017_English be delivered?Answer: Upon your order, we will start to translate YY/T 1596-2017_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 1596-2017_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 1596-2017_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
