Since 2016, the medical device industry has further highlighted the importance of regulations and the necessity and necessity of implementing the regulations. It aims to further ensure the safety and effectiveness of all stages of the medical device life cycle, and also supplements the medical device after its launch. New requirements for supervision and improvement. Today, the medical device industry is gradually improving, and the medical device industry is also favored by policies and markets. The new regulations for ISO medical equipment are officially in force. CFDA introduces international standards. On May 1, the YY/T0287-2017 /ISO13485:2016 "Requirements for the use of medical device quality management systems for regulatory requirements" approved by the State Food and Drug Administration (CFDA) was officially implemented. CFDA introduced ISO international standards, CFDA said that YY/T0287-2017 "Medical Device Quality Management System for Regulatory Requirements" (hereinafter referred to as the new standard) is equivalent to the ISO13485:2016 standard. The ISO13485 standard is a quality management system standard applied in the field of medical devices. It focuses on the safety and effectiveness of medical devices, and emphasizes that medical devices provided by organizations must meet customer requirements and regulatory requirements. China independently develops the medical system China attaches importance to the latest ISO13485 standard. The production methods and marketing models of medical devices are constantly changing, and the ISO13485 standard is constantly being revised. Prior to this, in 1996 and 2003, ISO published two different versions of the standard guides in 1996 and 2003 respectively. The 2016 version was released for implementation in March 2016. At the same time as international standards, China's own medical system has also been formulated and released. Also implemented on May 1, there are also "Administrative Measures for Medical Device Recall". According to the Measures, medical device recalls are divided into three levels according to the severity of medical device defects. After the medical device manufacturer makes a recall decision, the first, second and third level recalls shall be notified within 1 day, within 3 days and within 7 days, respectively, to the relevant medical device operating enterprise, user unit or inform the user. In addition, the CFDA also revised the original "Measures for the Administration of Medical Device Standards (Trial)", and the "Measures for the Administration of Medical Device Standards" will be implemented on July 1, 2017. CFDA said that this move will play a positive role in guiding the standardization management of medical devices in China, standardizing and standardizing standards, promoting the implementation and improvement of standards, and improving the quality of medical devices. National Food and Drug Administration issued medical device priority approval procedures In November 2016, the CFDA issued the “Medical Device Priority Approval Processâ€. According to the procedure, CFDA implements priority approval for two types of medical devices, including prioritizing technical review, prioritizing medical device registration quality management system verification, and prioritizing administrative approval. Accelerating the efficiency of review and approval in all aspects will shorten the time to market and ensure that the corresponding results and products can be applied to clinical use as soon as possible. It will take effect on January 1, 2017. The issuance of this procedure is a concrete manifestation of the implementation of the State Council's requirements for transforming government functions and promoting the work of “distributing servicesâ€. It will further promote the development of China's medical device industry, promote the urgent need for clinical products and other products to enter the market as soon as possible, and improve the people's health. Health level. The future transformation of equipment manufacturers and agents under the two-vote system Coincidentally, under the two-vote system, producers of consumables and reagents are bound to face the transformation of the channel model, and the transformation involves a wide range of issues, not only the channel model changes, but also the classification and re-selection of agents, price adjustments and taxes, Financial and compliance considerations. Rapid test kits are designed for use where a preliminary screening test result is required and are especially useful in resource-limited settings.
• Same-day results provide timely treatment possibility.
[Test Principle]
Urobilinogen:Urobilinogen with diazonium salt produce red violet dyes in strong acid medium.
Bilirubin:The direct bilirubin with dichlorobenzene diazonium produce azo dyes in acid medium.
Ketone:The acetoacetic acid and sodium nitroprusside cause reaction in alkaline medium,which produces red violet compound.
Blood:Hemoglobin acts as peroxidase. It can cause peroxidase release neo-ecotypes oxide (O).(O) oxidizes the indicator and make the color change subsequently.
Protein:It is based on a specific pH indicator attracted by cation on protein molecule,the indicator further ionized and make the color change.This phenomenon is called protein-error-of -indicator principle.
Nitrite:Nitrite and aromatic amine are diazotized to form a diazonium compound.The diazonium compound reacts with tetrahydrobenzo(h)quinolin 3-phenol produce the red azo dye.
Leukocyte:Pyrrole amino acid ester produce free phenol under the hydrolysis of esterase in neutrophile granulocyte,the free phenol couple with phenyl diazonium salt produce purple azo dyes.
Glucose:The glucose oxidized by glucose oxidase catalyzes the formation of glucuronic acid and peroxide hydrogen.Peroxide hydrogen releases neo-ecotypes oxide(O)under the function of peroxidase.(O)oxidizes tetramethyl benzidine, which make the color change.
Specific Gravity:Methyl vinyl ether and maleic acid copolymer is weak acid (-COOH) exchanger,the M+ cation (the major is Na+) in urine reacts with the exchanger and release hydrogen ion,hydrogen ion reacts with indicator produce color change.
pH:The method of pH indicator is applied.
Ascorbic Acid:Ascorbic acid deoxidizes the 2.6-dichlorphenolindophenol dye into colorless in alkaline medium.
Microalbumin:Sulfone phthalein dye has high sensitivity to microalbumin by the method of protein error.
Creatinine:Creatinine with 3,5-Dinitrobenoic acid produce violet compound in alkaline medium.
Calcium:Calcium ion reacts with methyl bromothymol blue produce color change in alkaline medium.
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• High quality
• Quick (10 minutes to 2 hours) and easy to perform .
• Tests based on agglutination, immuno-chromatographic, immuno-dot, and/or immuno-filtration techniques.
• Are suitable for individual or a limited number of samples, and require little or no additional equipment, which make them more economical than ELISAs in fully equipped laboratories.
• Possibility to store at room temperature for an extended period of time.