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YY/T 1725-2020 English PDF

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US$189.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1725-2020: Multiplex nucleic acid detection kit for infection of microorganisms
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1725-2020	189	Add to Cart	3 days	Multiplex nucleic acid detection kit for infection of microorganisms	Valid

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Basic data

Standard ID: YY/T 1725-2020 (YY/T1725-2020)
Description (Translated English): Multiplex nucleic acid detection kit for infection of microorganisms
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C30
Classification of International Standard: 11.040.30
Word Count Estimation: 10,186
Date of Issue: 2020-06-30
Date of Implementation: 2021-12-01
Issuing agency(ies): State Drug Administration

YY/T 1725-2020: Multiplex nucleic acid detection kit for infection of microorganisms

---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.
Multiplex nucleic acid detection kit for infection of microorganisms ICS 11.040.30 C30 People's Republic of China Pharmaceutical Industry Standard Bacterial and fungal infection multiple nucleic acid detection kit 2020-06-30 released 2021-12-01 implementation Issued by the State Drug Administration

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009. Please note that certain contents of this document may involve patents. Publication of this document The agency is not responsible for identifying these patents. This standard was proposed by the State Drug Administration. This standard is under the jurisdiction of the National Medical Clinical Laboratory and In Vitro Diagnostic System Standardization Technical Committee (SAC/TC136). Drafting organizations of this standard. China Institute for Food and Drug Control, Boao Biological Group Co., Ltd., Beijing Institute of Medical Device Inspection, Tianjin Huada Medical Laboratory Co., Ltd., Hunan Shengxiang Biotechnology Co., Ltd., Mérieux Diagnostic Products (Shanghai) Co., Ltd., Saipei (Shanghai) Trading Co., Ltd., Guangzhou Wanfu Biotechnology Co., Ltd., Shanghai Fosun Long March Medical Science Co., Ltd., Luminex Trading (Part 1 Sea) Co., Ltd. The main drafters of this standard. Liu Donglai, Zhang Chuntao, Zhou Haiwei, Shi Dawei, Shen Shu, Tian Yabin, Zhang Yan, Dai Leiying, Gong Yanping, Deng Zhongping, Ma Lingli, Li Chaorui, Cai Lei, Xia Yi, Su Hongbo. Bacterial and fungal infection multiple nucleic acid detection kit

1 Scope

This standard specifies the terms, definitions, requirements, and tests of multiple nucleic acid detection kits for bacterial and fungal infections (hereinafter referred to as "kits") Methods, labels and instructions for use, packaging, transportation and storage, etc. This standard applies to human samples (including blood, cerebrospinal fluid, feces, etc.) or their cultures for a single test, which can report 3 types and more. Quality control of kits for bacteria and fungi (hereinafter referred to as "pathogenic bacteria", excluding mycoplasma and chlamydia). Suitable for detection principles Kits for polymerase chain reaction isothermal amplification and second-generation sequencing technologies. This standard does not apply to kits that can report 1 or 2 pathogens in a single test. Not applicable to a single test can report 1 or Kits for different genes of two pathogens. Not applicable to a single test that can report different types of 1 or 2 pathogens (genotype or Serotype) kit.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this article Pieces. For undated references, the latest version (including all amendments) applies to this document. GB/T 191 Packaging, storage and transportation pictorial signs GB/T 29791.2 Information provided by manufacturers of in vitro diagnostic medical devices (labeling) Part 2.Professional in vitro diagnostic reagents

3 Terms and definitions

The following terms and definitions apply to this document. 3.1 Nucleic acid A class of biological macromolecules connected by nucleotides or deoxynucleotides through 3',5'-phosphodiester bonds. Note. It has very important biological functions, mainly storing genetic information and transmitting genetic information. Includes ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) Two types.

4 requirements

4.1 Appearance The appearance should meet but not limited to the following requirements. a) Each component of the kit should be complete and complete, with no liquid leakage; b) Chinese packaging labels should be clear and free from wear. 4.2 Nucleic acid extraction function The nucleic acid extraction function should meet the following requirements. a) For kits containing nucleic acid extraction components, the manufacturer shall make appropriate requirements for nucleic acid extraction and verify the nucleic acid extraction function; ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1725-2020_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1725-2020_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 1725-2020_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1725-2020_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+ countries

Question 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.