YY/T 1201-2013 English PDF

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YY/T 1201-2013: Urea assay kit(Enzyme coupling kinetic method)
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 1201-2013	229	Add to Cart	3 days	Urea assay kit(Enzyme coupling kinetic method)	Valid

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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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