HOME   Cart(0)   Quotation   About-Us Policy PDFs Standard-List
www.ChineseStandard.net Database: 189759 (12 Oct 2025)

YY/T 1424-2016 English PDF

US$139.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1424-2016: Chlamydia trachomatis DNA detection kit (fluorescent PCR)
Status: Valid
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 1424-2016English139 Add to Cart 3 days [Need to translate] Chlamydia trachomatis DNA detection kit (fluorescent PCR) Valid YY/T 1424-2016

PDF similar to YY/T 1424-2016


Standard similar to YY/T 1424-2016

YY/T 1515   YY/T 1516   YY/T 1514   YY/T 1422   YY/T 1421   

Basic data

Standard ID YY/T 1424-2016 (YY/T1424-2016)
Description (Translated English) Chlamydia trachomatis DNA 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 7,768
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, labeling, labeling, instruction manual, packaging, shipping and storage of Chlamydia trachomatis DNA detection kit (Fluorescent PCR). This standard applies to the principle of fluorescence PCR method, qualitative detection of human genitourinary secretions and other clinical samples of Chlamydia trachomatis DNA kit.

YY/T 1424-2016: Chlamydia trachomatis DNA 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.
Chlamydia trachomatis DNA detection kit (fluorescent PCR) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Chlamydia trachomatis DNA detection kit (Fluorescent PCR) 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. The drafting of this standard unit. China Food and Drug Administration Research Institute, Zhongshan University Daan Gene Co., Ltd. The main drafters of this standard. Mody Hill, Wang Bin, Gao Xuxian, Li Erhua. Chlamydia trachomatis DNA detection kit (Fluorescent PCR)

1 Scope

This standard specifies the requirements, test methods, labeling, labeling, and use of Chlamydia trachomatis DNA detection kits (Fluorescent PCR) Brochures, packaging, transportation and storage. This standard applies to the principle of fluorescence PCR method, qualitative detection of human genitourinary secretions and other clinical samples of Chlamydia trachomatis DNA kit.

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 (ISO 780) YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements (ISO 15223-1)

3 request

3.1 appearance The kit should be complete components, packaging appearance clean, no leakage, no damage; signs, label writing clear. 3.2 positive reference product compliance rate With the national positive reference material or the standard positive reference material for testing, the results should meet the corresponding requirements. 3.3 Negative reference product compliance rate With a national negative reference material or a standardized negative reference material for testing, the results should meet the corresponding requirements. 3.4 Minimum detection limit With the national minimum detection limit reference material or the standard minimum detection limit reference material for testing, the results should meet the corresponding requirements. 3.5 Repeatability With the national repetitive reference material or the standard repeatable reference material for testing, the results should be positive and Ct value of the coefficient of variation (CV,%) should be no more than 5%. 3.6 stability Can be valid for the stability and stability of the verification. a) Validity of the period. the manufacturer shall specify the validity of the product. Take a certain period of time after the product, test appearance, positive

Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1424-2016_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1424-2016_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 1424-2016_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1424-2016_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 [email protected]. 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.