Monoclonal dot-immunoenzyme test system for the detection of tularemia microbe (DIATul-M) according to TU 9388-040-01898109-2011 - phosphate-saline buffer (FSB) - 1 white tablet 1.01 g; - skimmed milk powder (lactalbumin) - cream-colored powder, 15 mg; - CATul (tularemia peroxidase immunoglobulin conjugate) is an amorphous brownish mass representing monoclonal immunoglobulins to lipopolysaccharide (LPS) F. tularensis, conjugated with horseradish peroxidase, lyophilized; - Tween-20 - viscous slightly yellowish liquid, 0.0075 ml; - DAB (3,3-diaminobenzidine) - brown powder, 2 mg; - hydroperite (urea, peroxide) - 1 white tablet 1.5 g; - positive control specimen (PCO-TM) - an amorphous mass of yellowish color, which is an inactivated lyophilized suspension of F. tularensis at a concentration of 1×109 m.q./ml; - Nitrocellulose membrane filter (FMNC in a Petri dish) - a white plate of 20×25 mm with 3×3 mm markings, sensitized with monoclonal mouse immunoglobulins to F. tularensis LPS with subsequent blocking with lactalbumin. The FMRC is placed in a single-use laboratory Petri dish with a lid, D 40 mm
Russia·342630·Russian Anti-Plague Institute "Microbe" of Rospotrebnadzor·Registered September 26, 2022·N/A- Device Name (English)
- Monoclonal dot-immunoenzyme test system for the detection of tularemia microbe (DIATul-M) according to TU 9388-040-01898109-2011 - phosphate-saline buffer (FSB) - 1 white tablet 1.01 g; - skimmed milk powder (lactalbumin) - cream-colored powder, 15 mg; - CATul (tularemia peroxidase immunoglobulin conjugate) is an amorphous brownish mass representing monoclonal immunoglobulins to lipopolysaccharide (LPS) F. tularensis, conjugated with horseradish peroxidase, lyophilized; - Tween-20 - viscous slightly yellowish liquid, 0.0075 ml; - DAB (3,3-diaminobenzidine) - brown powder, 2 mg; - hydroperite (urea, peroxide) - 1 white tablet 1.5 g; - positive control specimen (PCO-TM) - an amorphous mass of yellowish color, which is an inactivated lyophilized suspension of F. tularensis at a concentration of 1×109 m.q./ml; - Nitrocellulose membrane filter (FMNC in a Petri dish) - a white plate of 20×25 mm with 3×3 mm markings, sensitized with monoclonal mouse immunoglobulins to F. tularensis LPS with subsequent blocking with lactalbumin. The FMRC is placed in a single-use laboratory Petri dish with a lid, D 40 mm
- Device Name (Russian)
- Тест-система дот-иммуноферментная для детекции туляремийного микроба моноклональная (ДИАТул-М) по ТУ 9388-040-01898109-2011 - фосфатно-солевой буфер (ФСБ) - 1 таблетка белого цвета 1,01 г ; - молоко сухое обезжиренное (лактальбумин) - порошок кремового цвета, 15 мг; - МКАТул (конъюгат пероксидазный иммуноглобулиновый туляремийный) - аморфная масса коричневатого цвета, представляющая собой моноклональные иммуноглобулины к липополисахариду (ЛПС) F. tularensis, конъюгированные с пероксидазой хрена, лиофилизированные; - Тween-20 - вязкая слегка желтоватая жидкость, 0,0075 мл; - ДАБ (3,3´- диаминобензидин) - порошок коричневого цвета, 2 мг; - гидроперит (мочевины пероксид) - 1 таблетка белого цвета 1,5 г; - положительный контрольный образец (ПКО-ТМ) - аморфная масса желтоватого цвета, представляющая собой инактивированную лиофилизированную взвесь F. tularensis в концентрации 1×109 м.к./мл; - фильтр мембранный нитроцеллюлозный (ФМНЦ в чашке Петри) - пластина белого цвета 20×25 мм с нанесенной разметкой 3×3 мм, сенсибилизированная мышиными иммуноглобулинами моноклональными к ЛПС F. tularensis с последующей блокировкой лактальбумином. ФМНЦ помещена в чашку Петри с крышкой пластмассовую лабораторную однократного применения, D 40 мм
- Device Type (English)
- N/A
- Device Type (Russian)
- 342630
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 66007.0
- Registration Number
- ФСР 2012/13944
- 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 Monoclonal dot-immunoenzyme test system for the detection of tularemia microbe (DIATul-M) according to TU 9388-040-01898109-2011 - phosphate-saline buffer (FSB) - 1 white tablet 1.01 g; - skimmed milk powder (lactalbumin) - cream-colored powder, 15 mg; - CATul (tularemia peroxidase immunoglobulin conjugate) is an amorphous brownish mass representing monoclonal immunoglobulins to lipopolysaccharide (LPS) F. tularensis, conjugated with horseradish peroxidase, lyophilized; - Tween-20 - viscous slightly yellowish liquid, 0.0075 ml; - DAB (3,3-diaminobenzidine) - brown powder, 2 mg; - hydroperite (urea, peroxide) - 1 white tablet 1.5 g; - positive control specimen (PCO-TM) - an amorphous mass of yellowish color, which is an inactivated lyophilized suspension of F. tularensis at a concentration of 1×109 m.q./ml; - Nitrocellulose membrane filter (FMNC in a Petri dish) - a white plate of 20×25 mm with 3×3 mm markings, sensitized with monoclonal mouse immunoglobulins to F. tularensis LPS with subsequent blocking with lactalbumin. The FMRC is placed in a single-use laboratory Petri dish with a lid, D 40 mm in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФСР 2012/13944 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.