The test instrument reagent three certificates is the production license, medical device registration certificate or national food and drug approval number, business license.
Production license
Production license is the state for the production of a certain product and can guarantee the quality of the products of the enterprise, according to the law to grant permission to produce the product credentials.
Medical device registration certificate or national food and drug approval number
Medical device registration, is in accordance with legal procedures, to be marketed and sold, the use of medical devices, the safety and effectiveness of the systematic evaluation, in order to decide whether to agree with the process of its sale, use.
It is divided into the registration of medical devices within the territory and the registration of medical devices outside the territory, medical devices outside the territory, regardless of Class I, Class II, Class III should be handled by the State Food and Drug Administration (SFDA) in Beijing: within the territory of the Class I, Class II medical devices in the local provincial or municipal food and drug supervision bureau for the Class III to the State Food and Drug Administration for.
Business License
Business License is a proof that certain industries must be licensed under the law, and the competent authority handles the licensed business, such as tobacco monopoly license, drug business license, hazardous chemical business license, and so on.
Expanded Information:
There are four types of reagents:
1, inorganic analytical reagents
Inorganic analytical reagents are commonly used inorganic chemicals used for chemical analysis. Its purity is higher than that of industrial products and has fewer impurities.
2, organic analytical reagents
Reagents organic analytical reagents for the determination of the elements in the analysis of inorganic substances, separation, enrichment of precipitants, extractants, chelating agents, and indicators and other specialized organic compounds, rather than referring to general solvents, organic acids and organic bases. These organic reagents must have good sensitivity and selectivity. With the development of analytical chemistry and the chemical industry, will develop a better sensitivity and selectivity of such reagents, such as the emergence of some metal and ammonium ions since 1967 have the ability to complex the crown ether compounds is such.
3, the benchmark reagent
Benchmark reagent is a high purity, few impurities, good stability, chemical components of a constant compound. In the benchmark reagent volume analysis, pH measurement, calorimetry and other classifications. Each classification has the first benchmark and work benchmark points. Where the first benchmark must be verified by the National Academy of Metrology, the production unit is the use of the first benchmark as a working benchmark for the determination of product standards. Commercial operation of the benchmark reagent mainly refers to the volumetric analysis category of volumetric analysis work benchmark
4, standard substances
Standard substances are used in chemical analysis, instrumental analysis of chemical substances for comparison, or used to calibrate the instrumentation of chemicals. Its chemical composition, content, physical and chemical properties and impurities must be known, and in accordance with the provisions or recognized. Microanalytical reagent microanalytical reagent for the determination of the permitted amount of the substance is only one percent of the constant amount of the reagent for microanalysis.
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