|
US$209.00 ยท 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 | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1215-2013 | English | 209 |
Add to Cart
|
3 days [Need to translate]
|
Hepatitis C antibody diagnostic kit (Colloid gold method)
| Valid |
YY/T 1215-2013
|
PDF similar to YY/T 1215-2013
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]
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+ 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 [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.
|