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Free-β-subunit of human chorionic gonadotropin quantitative labelling immunoassay kit
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Basic data
| Standard ID | YY/T 1257-2015 (YY/T1257-2015) |
| Description (Translated English) | Free-��-subunit of human chorionic gonadotropin quantitative 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 | 9,930 |
| 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 free human chorionic gonadotropin �� sub-unit mark quantitative immunoassay kit classification, requirements, test methods, marking, labeling, instructions, packaging, transport and storage. This Standard applies to the determination of free human chorionic gonadotropin ��-subunit kit with double antibody sandwich method for the principle quantitatively. This Standard does not apply to: a) with colloidal gold or other methods of marking qualitative or semi-quantitative assay reagent free �� subunit of human chorionic gonadotropin (eg: test strip, etc.); b) radiolabelled with 125I, etc. all kinds of free human chorionic gonadotropin �� subunit RIA or IRMA kit. |
YY/T 1257-2015: Free-β-subunit of human chorionic gonadotropin quantitative labelling immunoassay kit
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Free-β-subunit of human chorionic gonadotropin quantitative labelling immunoassay kit
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Free β subunit of human chorionic gonadotropin
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. 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.
The standard by the China Research Institute of Food and Drug test drafted.
The main drafters of this standard. Ting, Huang Ying, Sun Nan, Liu Yan, the first noble.
Free β subunit of human chorionic gonadotropin
Quantitative labeled immunosorbent assay kit
1 Scope
This standard specifies the free β subunit of human chorionic gonadotropin labeled immunosorbent assay kit for quantitative classification, requirements, test side
France, logos, labels, brochures, packaging, transportation and storage.
This standard applies to the determination of free human chorionic gonadotropin β-subunit kit double antibody sandwich method for the principle quantitatively.
This standard does not apply to.
a) with colloidal gold or other qualitative or semi-quantitative determination of marker free β subunit of human chorionic gonadotropin agents (such as.
Test strip, etc.);
b) all kinds of free β subunit of human chorionic gonadotropin radiolabelled with 125I and other RIA or IRMA test
Cartridge.
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
Labeling methods can be divided according to the different enzyme label, (electro) chemiluminescent labels, (time-resolved) fluorescent labels; not according to the solid support
The same type can be divided into microplates, tubes, magnetic particle, microsphere beads and plastic beads and the like; depending on the operation process can be divided into manual method and apparatus
Automatic operation of law.
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
Should not be higher than 1.25ng/mL.
4.3 Linear
Within a predetermined linear interval kit, double logarithmic or other appropriate mathematical model fitting, the dose - response curve linear correlation coefficient
(R) shall not be less than 0.9900.
Note. The lower limit of the linear range of not more than 2.5ng/mL, the upper limit of the linear range of not less than 190ng/mL.
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