Enzyme-linked immunosorbent test system for the determination of cholera toxin production by Vibrio cholerae strains (IFAolXT-M) according to TU 9398-052-01898109-2015 Composed of: 1. Component No 1 - ACI medium hanging, 2 tubes of 12.12 g each. 2. Component No 2 - phosphate-salt buffer (FSB), 5 packets of 1.01 g each. 3. Component No 3 - skimmed milk powder (lactalbumin), 4 tubes of 0.0113 g. 4. Component No 4 - monoclonal peroxidase immunoglobulin conjugate (MCAHT conjugate), 1 tube 0.02 ml. 5. Component No 5 - glycerin, 1 tube 0.025 ml. 6. Component No 6 - tween-20, 4 tubes of 0.002 ml. 7. Component No 7 - citric acid, 4 test tubes of 0.0225 g. 8. Component No 8 - sodium citrate, 4 test tubes of 0.025 g. 9. Component No 9 - ABTS (2,2 ́-azino-bis-(3-ethylbenzthiazo-line-6-sulfonic acid), diammonium salt, 4 tubes of 0.001625 g. 10. Component No 10 - hydroperite, 4 test tubes of 0.067 g each. 11. Component No 11 - positive control sample (PCO-CT) - 4 tubes of 0.1 ml each. 12. Component No 12 - polystyrene plate of 12 strips of 8 wells, for enzyme-linked immunosorbent assay, single-use, processed, 1 pc.
Russia·190190·Russian Anti-Plague Institute "Microbe" of Rospotrebnadzor·Registered September 26, 2022·N/A- Device Name (English)
- Enzyme-linked immunosorbent test system for the determination of cholera toxin production by Vibrio cholerae strains (IFAolXT-M) according to TU 9398-052-01898109-2015 Composed of: 1. Component No 1 - ACI medium hanging, 2 tubes of 12.12 g each. 2. Component No 2 - phosphate-salt buffer (FSB), 5 packets of 1.01 g each. 3. Component No 3 - skimmed milk powder (lactalbumin), 4 tubes of 0.0113 g. 4. Component No 4 - monoclonal peroxidase immunoglobulin conjugate (MCAHT conjugate), 1 tube 0.02 ml. 5. Component No 5 - glycerin, 1 tube 0.025 ml. 6. Component No 6 - tween-20, 4 tubes of 0.002 ml. 7. Component No 7 - citric acid, 4 test tubes of 0.0225 g. 8. Component No 8 - sodium citrate, 4 test tubes of 0.025 g. 9. Component No 9 - ABTS (2,2 ́-azino-bis-(3-ethylbenzthiazo-line-6-sulfonic acid), diammonium salt, 4 tubes of 0.001625 g. 10. Component No 10 - hydroperite, 4 test tubes of 0.067 g each. 11. Component No 11 - positive control sample (PCO-CT) - 4 tubes of 0.1 ml each. 12. Component No 12 - polystyrene plate of 12 strips of 8 wells, for enzyme-linked immunosorbent assay, single-use, processed, 1 pc.
- Device Name (Russian)
- Тест-система иммуноферментная для определения продукции холерного токсина штаммами Vibrio cholerae (ИФАХолХТ-М) по ТУ 9398-052-01898109-2015 в составе: 1. Компонент № 1 - навеска среды АКI, 2 пробирки по 12,12 г. 2. Компонент № 2 - фосфатно-солевой буфер (ФСБ), 5 пакетов по 1,01 г. 3. Компонент № 3 - молоко сухое обезжиренное (лактальбумин), 4 пробирки по 0,0113 г. 4. Компонент № 4 - конъюгат пероксидазный иммуноглобулиновый моноклональный (конъюгат МКАХТ), 1 пробирка 0,02 мл. 5. Компонент № 5 - глицерин, 1 пробирка 0,025 мл. 6 .Компонент № 6 - tween-20, 4 пробирки по 0,002 мл. 7. Компонент № 7 - кислота лимонная, 4 пробирки по 0,0225 г. 8 .Компонент № 8 - натрия цитрат, 4 пробирки по 0,025 г. 9. Компонент № 9 - ABTS (2,2´-azino-bis-(3-ethylbenzthiazo-line-6-sulfonic acid), diammonium salt, 4 пробирки по 0,001625 г. 10. Компонент № 10 - гидроперит, 4 пробирки по 0,067 г. 11. Компонент № 11 - положительный контрольный образец (ПКО-ХТ) - 4 пробирки по 0,1 мл. 12. Компонент № 12 - планшет 12 стрипов по 8 лунок полистироловый, для иммуноферментного анализа, однократного применения, обработанный, 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 190190
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 65969.0
- Registration Number
- РЗН 2016/5013
- Registration Date
- September 26, 2022
- Manufacturer Name (English)
- Russian Anti-Plague Institute "Microbe" of Rospotrebnadzor
- Manufacturer Name (Russian)
- ФКУН Российский противочумный институт "Микроб" Роспотребнадзора
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- Russian Anti-Plague Institute "Microbe" of Rospotrebnadzor, Russia, 410005, Saratov, Universitetskaya str., 46
- Legal Address (Russian)
- ФКУН Российский противочумный институт "Микроб" Роспотребнадзора, Россия, 410005, г. Саратов, ул. Университетская, д. 46
- Manufacturing Address
- 410005, Россия, Саратовская область, г. Саратов, ул. Университетская, д. 46
Access comprehensive regulatory information for Enzyme-linked immunosorbent test system for the determination of cholera toxin production by Vibrio cholerae strains (IFAolXT-M) according to TU 9398-052-01898109-2015 Composed of: 1. Component No 1 - ACI medium hanging, 2 tubes of 12.12 g each. 2. Component No 2 - phosphate-salt buffer (FSB), 5 packets of 1.01 g each. 3. Component No 3 - skimmed milk powder (lactalbumin), 4 tubes of 0.0113 g. 4. Component No 4 - monoclonal peroxidase immunoglobulin conjugate (MCAHT conjugate), 1 tube 0.02 ml. 5. Component No 5 - glycerin, 1 tube 0.025 ml. 6. Component No 6 - tween-20, 4 tubes of 0.002 ml. 7. Component No 7 - citric acid, 4 test tubes of 0.0225 g. 8. Component No 8 - sodium citrate, 4 test tubes of 0.025 g. 9. Component No 9 - ABTS (2,2 ́-azino-bis-(3-ethylbenzthiazo-line-6-sulfonic acid), diammonium salt, 4 tubes of 0.001625 g. 10. Component No 10 - hydroperite, 4 test tubes of 0.067 g each. 11. Component No 11 - positive control sample (PCO-CT) - 4 tubes of 0.1 ml each. 12. Component No 12 - polystyrene plate of 12 strips of 8 wells, for enzyme-linked immunosorbent assay, single-use, processed, 1 pc. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2016/5013 and manufactured by Russian Anti-Plague Institute "Microbe" of Rospotrebnadzor. The device was registered on September 26, 2022.
This page provides complete registration details including device type, manufacturer information, country of origin (Russia), and regulatory compliance data from the official Russia Roszdravnadzor medical device database. Pure Global AI offers free access to Russia's complete medical device registry, helping global MedTech companies navigate Roszdravnadzor regulations efficiently.