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YY/T 1201-2013: Urea assay kit(Enzyme coupling kinetic method)
Status: Valid
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 1201-2013 | English | 229 |
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Urea assay kit(Enzyme coupling kinetic method)
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YY/T 1201-2013
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Basic data | Standard ID | YY/T 1201-2013 (YY/T1201-2013) | | Description (Translated English) | Urea assay kit(Enzyme coupling kinetic method) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C44 | | Classification of International Standard | 11.100 | | Word Count Estimation | 10,164 | | 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: urea assay kit (enzyme-coupled monitoring method) Determination of Principles, requirements, test methods, marking, labeling and instructions for use, packaging, transportation and storage. This standard applies to: urea assay kit | YY/T 1201-2013: Urea assay kit(Enzyme coupling kinetic 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.
Urea assay kit (Enzyme coupling kinetic method)
ICS 11.100
C44
People's Republic of China pharmaceutical industry standards
Urea Assay Kit (enzyme-coupled monitoring method)
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
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 drafting unit. China Academy of Food and Drug test.
The main drafters of this standard. Wang Yumei, Huangbao Bin, Liu Yan, the first noble.
Urea Assay Kit (enzyme-coupled monitoring method)
1 Scope
This standard specifies the urea assay kit (enzyme-coupled monitoring method) measurement principle, requirements, test methods, marking, labeling and instructions for use
Books, packaging, transportation and storage.
This standard applies to urea assay kit (enzyme-coupled monitoring method) quality control.
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 Principle of Measurement
Urea at a urea enzyme hydrolysis NH4 CO2, under and NH4, NADH and α- ketoglutarate glutamate dehydrogenase
Generates CO2, glutamate and NAD. Since NADH is oxidized to the NAD, reducing the absorbance at 340nm, the absorbance value decreased with
It is proportional to the concentration of urea.
4 Requirements
4.1 Appearance
Compatible with the manufacturer's normal appearance requirements.
4.2 PACKING
Net content of the liquid reagent to be less than the labeled amount.
4.3 reagent blank
4.3.1 Reagent blank absorbance
It should not be less than 1.0 (a wavelength of 340nm, light trails 1.0cm).
4.3.2 Reagent blank absorbance change rate
Should not be greater than 0.04/min.
4.4 linear range
In 0.9mmol/L ~ 35.7mmol/L range, the linear theory of concentration and measured concentration shall be not less than the correlation coefficient r
0.9900.
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