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YY/T 1258-2015: Homocysteine assay kit(enzymatic cycling method)
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Std ID	Version	USD	Buy	Deliver [PDF] in	Title (Description)
YY/T 1258-2015	English	239	Add to Cart	3 days [Need to translate]	Homocysteine assay kit(enzymatic cycling method)

YY/T 1258-2015: Homocysteine assay kit(enzymatic cycling method)

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Homocysteine assay kit (enzymatic cycling method) ICS 11.100 C44 People's Republic of China Pharmaceutical Industry Standard Homocysteine assay reagent (cassette) (enzyme circulation method) 2015-03-02 release 2016-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. Please note that some of the contents of this document may involve patents. The release of this document The Agency does not assume responsibility for identifying these patents. This standard is proposed by the State Food and Drug Administration. This standard by the National Medical Laboratory Laboratory and in vitro diagnostic system Standardization Technical Committee (SAC/TC136) centralized. The drafting of this standard. Beijing Medical Device Testing Institute, Beijing nine strong biotechnology Co., Ltd., Ningbo US Kang biotechnology stocks Co., Ltd., Parkinson Biological Engineering (Beijing) Co., Ltd. The main drafters of this standard. Bi Chunlei, Chen Yang, Zou Bingde, Kang Juan, Shi Fuqin. Homocysteine assay reagent (cassette) (enzyme circulation method)

1 Scope

This standard specifies the requirements for homocysteine assay reagents (enzyme) (enzyme cycle), test methods, labels, instructions, packaging, Transportation and storage. This standard is applicable to reagents (cartridges) for quantitative detection of homocysteine in human serum or plasma using an enzyme circulation method, The principle of photometric method, including manual reagents and reagents used in semi-automatic, fully automated biochemical analyzers.

2 normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this article Pieces. For undated references, the latest edition (including all modifications) applies to this document. YY/T 0466.1 Symbols for medical devices for labeling, labeling and providing information on medical devices - Part 1. General requirements

3 request

3.1 appearance Appearance should meet the following requirements. a) kit components should be complete, complete, liquid without leakage; b) packaging label text symbols should be clear. 3.2 Capacity Should not be less than the marked value. 3.3 Reagent blank The initial absorbance of the reagents for the ascending reaction is not greater than 0.05, and the initial absorbance of the reagent for the descending reaction is not less than 0.8. 3.4 Analysis of sensitivity For the endpoint test, the absorbance change (ΔA) of the 10.0 μmol/L sample should be not less than 0.02. For the rate test reagent, the absorbance change rate (ΔA/min) of the 10.0 μmol/L sample should be not less than 0.01. 3.5 Linearity The linear range of reagent (box) should be covered [3.0,45.0] μmol/L. a) linear correlation coefficient ︱ r︱ should not be less than 0.995; b) The linear deviation should not exceed ± 1.0 μmol/L or the linear deviation should not exceed ± 10%. 3.6 precision 3.6.1 Repeatability 3.6.1.1 Repeat the test (10.0 ± 2.0) μmol/L of the sample, the results of the coefficient of variation (CV) should not be greater than 5%. ...