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Information × Registration Number 0213U002369, 0110U005235 , R & D reports Title Development and introduction for further manufacturing of sensoric device for Helicobacter Pylori in stomach express-diagnostics popup.stage_title Head Shandrenko Sergey Grygorevich., Registration Date 25-01-2013 Organization A.V.Palladin Institute of Biochemistry of National Academy of Sciences popup.description2 The method of direct urease test for the diagnostics of human gastric helicobacteriosis has been developed. The principle of the method is based on determining the rate of ammonia concentration in the air of the patient's mouth after drug "carbamide" administration. In order to automatize the diagnostic urease test it was developed and produced an experimental device "Heliсotester." It was started the registration process of the designed apparatus as medical devices. It has been passed the state sanitary-epidemiological expertise TU (conclusion № 05.03.02-07/107077 on 04.11.2011), preclinical testing of the device (protocol number 3/8-A-9660 on 11/02/2011 p), expertise of technical documentations in "Polytechmed "(conclusion № 4/3-358 on 23.11.2011r). It have been obtained following protocols: electrical safety of the device № 0025-2-2012 on 14.02.2012 and № 2409-2-2012 on 30.10.2012, electromagnetic compatibility № 0024-5-2012 on 20.01.2012 and № 2408-5-2012 on 04.10.2012, the impact of operating, storage and transportation conditions № 2915-4-2012 on 03.12.2012 in "Ukrmetteststandart", the act of technical tests № 4/2874-2012 in the "Polytechmed." To complete the registration and implementation of the developed device it should be passed several additional steps: clinical trials, sanitary-epidemiological examination of the device, registration of TU. Product Description popup.authors Володіна Тетяна Терентіївна Крисюк Ірина Павлівна Парілова Олена Олександрівна Попова Наталія Миколаївна Шандренко Сергій Григорович popup.nrat_date 2020-04-02 Close