Francisella tularensis DNA reagent kit by polymerase chain reaction with real-time hybridization-fluorescence recording of results (Francisella tularensis gene-RGF) according to TU 9398-035-01898109-2011 Composed of: 1. PCR-mixture-1 is a transparent colorless liquid containing: a mixture of two primers (Synthol, Russia), each in a concentration of 8 pmol; probe (Synthol, Russia) at a concentration of 4 pmol; a mixture of deoxynucleoside triphosphates (dNTP) - dATP, dGTP, dCTP, dTTP (SibEnzyme, Russia), each in a concentration of 1 mmol; sodium azide (Sigma, USA, or similar) - 0.031%. 2. PCR mixture-2 is a clear colorless liquid containing Tris-HCl - 187.5 mmol, pH 8.8 at a temperature of 25°C ("Fermentas", USA, or similar); ammonium sulfate (Fermentas, USA, or similar) - 50 mmol; magnesium chloride (Fermentas, USA, or similar) - 5.0 mmol; Tween-20 (Fermentas, USA, or similar) - 0.025%. 3. Taq DNA polymerase - transparent colorless liquid ("Fermentas", USA) - 5 units/μl. 4. TE-buffer is a clear colorless liquid containing Tris-HCl (Amresco, USA) -10 mmol; Na2-EDTA (Amresco, USA) - 1 mmol. 5. Positive F. tularensis DNA control sample (F. tularensis DNA PCS) is a clear, colorless liquid that is an aqueous solution of F. tularensis DNA at a concentration of 1 ng.
Russia·139940·Russian Anti-Plague Institute "Microbe" of Rospotrebnadzor·Registered September 28, 2022·Class 2b- Device Name (English)
- Francisella tularensis DNA reagent kit by polymerase chain reaction with real-time hybridization-fluorescence recording of results (Francisella tularensis gene-RGF) according to TU 9398-035-01898109-2011 Composed of: 1. PCR-mixture-1 is a transparent colorless liquid containing: a mixture of two primers (Synthol, Russia), each in a concentration of 8 pmol; probe (Synthol, Russia) at a concentration of 4 pmol; a mixture of deoxynucleoside triphosphates (dNTP) - dATP, dGTP, dCTP, dTTP (SibEnzyme, Russia), each in a concentration of 1 mmol; sodium azide (Sigma, USA, or similar) - 0.031%. 2. PCR mixture-2 is a clear colorless liquid containing Tris-HCl - 187.5 mmol, pH 8.8 at a temperature of 25°C ("Fermentas", USA, or similar); ammonium sulfate (Fermentas, USA, or similar) - 50 mmol; magnesium chloride (Fermentas, USA, or similar) - 5.0 mmol; Tween-20 (Fermentas, USA, or similar) - 0.025%. 3. Taq DNA polymerase - transparent colorless liquid ("Fermentas", USA) - 5 units/μl. 4. TE-buffer is a clear colorless liquid containing Tris-HCl (Amresco, USA) -10 mmol; Na2-EDTA (Amresco, USA) - 1 mmol. 5. Positive F. tularensis DNA control sample (F. tularensis DNA PCS) is a clear, colorless liquid that is an aqueous solution of F. tularensis DNA at a concentration of 1 ng.
- Device Name (Russian)
- Набор реагентов для выявления ДНК Francisella tularensis методом полимеразной цепной реакции с гибридизационно-флуоресцентным учетом результатов в режиме реального времени (Ген Francisella tularensis-РГФ) по ТУ 9398-035-01898109-2011 в составе: 1. ПЦР-смесь-1 - прозрачная бесцветная жидкость, содержащая: смесь двух праймеров («Синтол», Россия), каждый в концентрации 8 пмоль; зонда («Синтол», Россия) в концентрации 4 пмоль; смесь дезоксинуклеозидтрифосфатов (дНТФ) - дАТФ, дГТФ, дЦТФ, дТТФ («СибЭнзим», Россия), каждый в концентрации 1 ммоль; натрия азида («Sigma», США, или аналогичный) - 0,031 %. 2. ПЦР-смесь-2 - прозрачная бесцветная жидкость, содержащая Трис-HCl - 187,5 ммоль, pH 8.8 при температуре 25°C («Fermentas», США, или аналогичный); аммония сульфат («Fermentas», США, или аналогичный) - 50 ммоль; магния хлорид («Fermentas», США, или аналогичный) - 5,0 ммоль; Тween-20 («Fermentas», США, или аналогичный) - 0,025 %. 3. Taq ДНК-полимераза - прозрачная бесцветная жидкость («Fermentas», США) - 5 ед/мкл. 4. ТЕ-буфер - прозрачная бесцветная жидкость, содержащая Трис-HCl («Amresco», США) -10 ммоль; Na2-ЭДТА («Amresco», США) - 1 ммоль. 5. Положительный контрольный образец ДНК F. tularensis (ПКО ДНК F. tularensis) - прозрачная бесцветная жидкость, представляющая собой водный раствор ДНК F. tularensis в концентрации 1 нг.
- Device Type (English)
- N/A
- Device Type (Russian)
- 139940
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 66013.0
- Registration Number
- ФСР 2011/12107
- Registration Date
- September 28, 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 Francisella tularensis DNA reagent kit by polymerase chain reaction with real-time hybridization-fluorescence recording of results (Francisella tularensis gene-RGF) according to TU 9398-035-01898109-2011 Composed of: 1. PCR-mixture-1 is a transparent colorless liquid containing: a mixture of two primers (Synthol, Russia), each in a concentration of 8 pmol; probe (Synthol, Russia) at a concentration of 4 pmol; a mixture of deoxynucleoside triphosphates (dNTP) - dATP, dGTP, dCTP, dTTP (SibEnzyme, Russia), each in a concentration of 1 mmol; sodium azide (Sigma, USA, or similar) - 0.031%. 2. PCR mixture-2 is a clear colorless liquid containing Tris-HCl - 187.5 mmol, pH 8.8 at a temperature of 25°C ("Fermentas", USA, or similar); ammonium sulfate (Fermentas, USA, or similar) - 50 mmol; magnesium chloride (Fermentas, USA, or similar) - 5.0 mmol; Tween-20 (Fermentas, USA, or similar) - 0.025%. 3. Taq DNA polymerase - transparent colorless liquid ("Fermentas", USA) - 5 units/μl. 4. TE-buffer is a clear colorless liquid containing Tris-HCl (Amresco, USA) -10 mmol; Na2-EDTA (Amresco, USA) - 1 mmol. 5. Positive F. tularensis DNA control sample (F. tularensis DNA PCS) is a clear, colorless liquid that is an aqueous solution of F. tularensis DNA at a concentration of 1 ng. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number ФСР 2011/12107 and manufactured by Russian Anti-Plague Institute "Microbe" of Rospotrebnadzor. The device was registered on September 28, 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.