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YY/T 1215-2013 English PDF

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US$209.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1215-2013: Hepatitis C antibody diagnostic kit (Colloid gold method)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1215-2013	209	Add to Cart	3 days	Hepatitis C antibody diagnostic kit (Colloid gold method)	Valid

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Basic data

Standard ID: YY/T 1215-2013 (YY/T1215-2013)
Description (Translated English): Hepatitis C antibody diagnostic kit (Colloid gold method)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 9,974
Quoted Standard: GB/T 191
Regulation (derived from): State Food and Drug Administration Notice No. 36 of 2013; industry standard for filing Notice 2013 No. 12 (No. 168 overall)
Issuing agency(ies): State Food and Drug Administration
Summary: This standard specifies: Hepatitis C virus (HCV) antibody detection kit (Colloidal Gold) Terminology and definitions, requirements, test methods, inspection and determination, packaging, marking and instructions for use, transport and storage. This standa

YY/T 1215-2013: Hepatitis C antibody diagnostic kit (Colloid gold method)

---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.
Hepatitis C antibody diagnostic kit (Colloid gold method) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Hepatitis C virus (HCV) antibody detection kit (Colloidal gold method) HepatitisCantibodydiagnostickit (Coloidgoldmethod) Issued on. 2013-10-21 2014-10-01 implementation China Food and Drug Administration released

Foreword

This standard was drafted in accordance with GB/T 1.1-2009 given rules. Please note that some of the content of this standard may involve patents. The standard release mechanism does not assume the responsibility to identify these patents. This standard was proposed by the China Food and Drug Administration. This standard by the national medical clinical laboratory testing and in vitro diagnostic systems for Standardization Technical Committee (SAC/TC136) centralized. This standard was drafted. Chinese Academy of Food and Drug test. The main drafters of this standard. Huang Jie, Wang Yumei, noble first. Hepatitis C virus (HCV) antibody detection kit (Colloidal gold method)

1 Scope

This standard specifies the hepatitis C virus (HCV) antibody detection kit (colloidal gold) terms and definitions, requirements, test methods, inspection Experience and judgment, packaging, labeling and instructions for use, transport and storage. This standard applies to hepatitis C virus (HCV) antibody detection rapid test kit (colloidal gold, colloidal selenium method, latex method strips Article kit). The kit for the qualitative detection of human whole blood, serum or plasma hepatitis C virus (HCV) antibodies.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein Member. For undated references, the latest edition (including any amendments) applies to this document. GB/T 191 Packaging - Pictorial signs

3 Terms and Definitions

The following terms and definitions apply to this document. 3.1 Colloidal gold coloidgoldtechnique Colloidal gold particles as tracers or coloring substances antigen-antibody reaction or one other marker molecule detection technology. 3.2 The minimum detectable amount lowestdetectionlimit Samples with a certain probability can be declared null and has the lowest value of the measured difference. 3.3 Analytical specificity analyticalspecificity Measurement procedure only measure the ability to be measured. 3.4 Repeatability repeatability Under the same measurement conditions, the same measurement was repeatedly measured consistency between the results obtained. [JJF1001-1998, the definition 5.6] 3.5 Reference substance (product) referencematerial; RM Having one or more sufficiently homogeneous and well established characteristics used to calibrate the measuring device or measuring method to evaluate the material assignment A material or substance. [JJF1001-1998, the definition 8.13] ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1215-2013_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1215-2013_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 1215-2013_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1215-2013_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.