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YY/T 1248-2014 English PDF

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US$229.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email.
YY/T 1248-2014: Hepatitis B virus surface antibody (HBsAb) detection reagent (kit) (Chemiluminescent immunoassay)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1248-2014	229	Add to Cart	3 days	Hepatitis B virus surface antibody (HBsAb) detection reagent (kit) (Chemiluminescent immunoassay)	Valid

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Basic data

Standard ID: YY/T 1248-2014 (YY/T1248-2014)
Description (Translated English): Hepatitis B virus surface antibody (HBsAb) detection reagent (kit) (Chemiluminescent immunoassay)
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 10,130
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Quoted Standard: GB/T 21415
Regulation (derived from): China Food and Drug Administration in 2014 Bulletin No. 30
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard applies to the use of chemiluminescence analysis, using the principle of double antigen sandwich qualitative or quantitative determination of human serum, plasma hepatitis B surface antibody reagent (box), including chemiluminescence, ECL, a

YY/T 1248-2014: Hepatitis B virus surface antibody (HBsAb) detection reagent (kit) (Chemiluminescent immunoassay)

---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 B virus surface antibody (HBsAb) detection reagent (kit) (Chemiluminescent immunoassay) ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Hepatitis B surface antibody assay reagent (kit) (Chemiluminescent immunoassay) HepatitisBvirussurfaceantibody (HBsAb) detectionreagent (kit) Issued on. 2014-06-17 2015-07-01 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 document may involve patents. Release mechanism of the present document does not assume responsibility for the identification of 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, Beijing Medical Device Testing, Roche Diagnostics (Shanghai) Co., Division, US Bureau of Beijing Biotechnology Co., Ltd., Abbott Trading (Shanghai) Co., Ltd. The main drafters of this standard. Zhou Cheng, Wangrui Xia, Du Haiou, Cai Xiaorong, Cheng Yinghao, Wang Xuefeng. Hepatitis B surface antibody assay reagent (kit) (Chemiluminescent immunoassay)

1 Scope

This standard specifies the hepatitis B surface antibody assay reagent (kit) (chemiluminescent immunoassay) technical requirements, test methods, Logos, labels, brochures, packaging, transportation and storage. This standard applies to the use of chemiluminescence analysis, using the principle of double antigen sandwich method qualitative or quantitative determination of human serum, plasma beta Hepatitis virus surface antibody (hereinafter referred to as "HBsAb") reagent (box). Including chemiluminescence, ECL, and time-resolved fluorescence method. This standard does not apply to. a) intended for sale separate hepatitis B surface antibody calibrators and control materials hepatitis B surface antibody; b) by CLIA for the principle of biochips.

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 21415 in vitro diagnostic medical devices - Measurement of quantities in biological samples calibration and control materials assigned metrological traceability Derived

3 Requirements

3.1 Quantitative assay reagent (kit) 3.1.1 Appearance Shall meet the following requirements. a) a liquid component should be clear and transparent; b) reagent (box) of each component should be complete, complete, no liquid leakage; Chinese packaging labels should be clear, no damage. 3.1.2 Traceability Manufacturers should provide a source of calibrators used according to GB/T 21415 and the relevant provisions, assignment methods, and uncertainty and so on. 3.1.3 Accuracy With HBsAb national reference or standardized by the National Reference Reference products as samples for testing, the relative deviation of measurement results It should be within ± 20% range. 3.1.4 reference material negative coincidence rate With the national reference or standardized by the National Reference negative reference materials were determined not appear positive. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1248-2014_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1248-2014_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 1248-2014_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1248-2014_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.