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YY/T 1252-2015 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 1252-2015: Total IgE guantitative labelling immunoassay kit
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1252-2015	189	Add to Cart	3 days	Total IgE guantitative labelling immunoassay kit	Valid

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Basic data

Standard ID: YY/T 1252-2015 (YY/T1252-2015)
Description (Translated English): Total IgE guantitative labelling immunoassay kit
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C44
Classification of International Standard: 11.100
Word Count Estimation: 9,959
Date of Issue: 2015-03-02
Date of Implementation: 2016-01-01
Quoted Standard: GB/T 191; YY/T 0466.1
Regulation (derived from): The State Food and Drug Administration Announcement 2015 No. 8
Issuing agency(ies): State Food and Drug Administration
Summary: This Standard specifies the total IgE labeled immunosorbent assay kit for the quantitative quality requirements, test methods, instructions for use, marking, labeling and packaging, transportation and storage. This Standard applies to conduct quantitative determination of total IgE labeled immunoassay kit. Include enzyme labels, chemiluminescent labels, etc. as the capture antibody labeling method, in microplates, tubes, magnetic particles, beads and plastic beads as the carrier coating antibody, quantitative determination of total IgE assay kit for immunoassay. This Standard does not apply to: a) colloidal gold-labeled total IgE test strip; b) radiolabelled with 125I and other types of RIA or IRMA kit.

YY/T 1252-2015: Total IgE guantitative labelling immunoassay kit

---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.
Total IgE guantitative labelling immunoassay kit ICS 11.100 C44 People's Republic of China pharmaceutical industry standards Total IgE quantitative labeled immunosorbent assay kit Issued on. 2015-03-02 2016-01-01 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. Distribution of this document Institutions do 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. Sun Nan, Liu Yan, Yu Ting, Wang Yumei, noble first. Total IgE quantitative labeled immunosorbent assay kit

1 Scope

This standard specifies the total IgE labeled immunosorbent assay kit for quantitative quality requirements, test methods, instructions for use, marking, labeling and package Equipment, transportation and storage. This standard applies to the quantitative determination of total IgE were labeled immunoassay kit (hereinafter referred to as the kit). Include enzyme labels, of Chemiluminescent label and the like methods for the capture antibody to microtiter plates, tubes, magnetic particles, beads and plastic beads as the carrier coating antibody, quantitative measurement Total IgE immunoassay assay kit. This standard does not apply to. a) colloidal gold-labeled total IgE test strip; b) radiolabeled with 125I and other types of RIA or IRMA kit.

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 Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements Category 3 The kit can be divided according to different labeling methods ELISA, chemiluminescence, immunofluorescence and other kit, according to the solid support Different type can be divided into microplates, tubes, magnetic particles, beads and plastic beads as the carrier of the kit; based on the operation can be divided into hand Duplex operation method and apparatus for automatic operation method of the kit.

4 Requirements

4.1 Appearance Manufacturers should be based on the characteristics of the packaging of their products provide adequate appearance requirements. Usually the kit components should be composed of characters; inside and outside Packaging, labeling and other requirements clear. 4.2 blank Limit Blank limit should not exceed 5.0IU/mL. 4.3 Linear Within a given manufacturer's range of linear correlation coefficient (r) shall not be less than 0.9900. Note. The lower limit of the linear range of not more than 5IU/mL, the upper limit of the linear range of not less than 1000IU/mL. 4.4 Accuracy Accuracy should meet one of the requirements are as follows. ......

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Tips & Frequently Asked Questions:

Question 1: How long will the true-PDF of YY/T 1252-2015_English be delivered?

Answer: Upon your order, we will start to translate YY/T 1252-2015_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 1252-2015_English with my colleagues?

Answer: Yes. The purchased PDF of YY/T 1252-2015_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.