Reagent kit for the detection of DNA of the tularemia pathogen by polymerase chain reaction taking into account the results in real time (GenTool - indication - RGF) according to TU 9398-049-01898109-2014 Includes: 1. PCR-mixture-1 - dry, in the form of a lilac sediment, containing: a mixture of two primers (CJSC "Synthol", Russia), each in a concentration of 8 pmol/l; probe (CJSC "Synthol", Russia) at a concentration of 4 pmol/l, a mixture of deoxynucleoside triphosphates (dNTP) - dATP, dGTP, dCTP, dTTP (CJSC "Synthol", Russia), each at a concentration of 1 mmol/l; sodium azide (Amresco, USA) - 3 mmol/l; 2. PCR-mixture-RGF - transparent violet liquid containing Tris-HCl - 125 mmol/l, pH 8.8 at 25°C (CJSC "Synthol", Russia); potassium chloride (CJSC "Synthol", Russia) - 125 mmol/l; magnesium chloride (CJSC "Synthol", Russia) - 5.0 mmol/l; Tween-20 (CJSC "Synthol", Russia) - 0.05 mmol/l, glycerin ("Amresco", USA) - 17 mmol/l, sodium azide ("Amresco", USA) - 3.75 mmol/l; 3. Taq DNA polymerase - Syn Taq DNA polymerase with enzyme inhibitors, transparent colorless liquid (CJSC "Synthol", Russia) - 5 units/μl; 4. Solvent - a clear, colorless liquid that is H2O, free of nucleases ("Fermentas", USA); 5. TE-buffer - clear colorless liquid containing Tris-HCl ("Amresco", USA) - 10 mmol; Na2-EDTA ("Amresco", USA) - 1 mmol; 6. Positive F. tularensis DNA control sample (F. TULARENSIS DNA PCO) - dry, in the form of a trace of a dried drop at the bottom of the test tube, which is F. tularensis DNA isolated from a bacterial suspension of a tularemia microbe with a concentration of 1×106 m.k./ml.
Russia·139940·Russian Anti-Plague Institute "Microbe" of Rospotrebnadzor·Registered September 28, 2022·N/A- Device Name (English)
- Reagent kit for the detection of DNA of the tularemia pathogen by polymerase chain reaction taking into account the results in real time (GenTool - indication - RGF) according to TU 9398-049-01898109-2014 Includes: 1. PCR-mixture-1 - dry, in the form of a lilac sediment, containing: a mixture of two primers (CJSC "Synthol", Russia), each in a concentration of 8 pmol/l; probe (CJSC "Synthol", Russia) at a concentration of 4 pmol/l, a mixture of deoxynucleoside triphosphates (dNTP) - dATP, dGTP, dCTP, dTTP (CJSC "Synthol", Russia), each at a concentration of 1 mmol/l; sodium azide (Amresco, USA) - 3 mmol/l; 2. PCR-mixture-RGF - transparent violet liquid containing Tris-HCl - 125 mmol/l, pH 8.8 at 25°C (CJSC "Synthol", Russia); potassium chloride (CJSC "Synthol", Russia) - 125 mmol/l; magnesium chloride (CJSC "Synthol", Russia) - 5.0 mmol/l; Tween-20 (CJSC "Synthol", Russia) - 0.05 mmol/l, glycerin ("Amresco", USA) - 17 mmol/l, sodium azide ("Amresco", USA) - 3.75 mmol/l; 3. Taq DNA polymerase - Syn Taq DNA polymerase with enzyme inhibitors, transparent colorless liquid (CJSC "Synthol", Russia) - 5 units/μl; 4. Solvent - a clear, colorless liquid that is H2O, free of nucleases ("Fermentas", USA); 5. TE-buffer - clear colorless liquid containing Tris-HCl ("Amresco", USA) - 10 mmol; Na2-EDTA ("Amresco", USA) - 1 mmol; 6. Positive F. tularensis DNA control sample (F. TULARENSIS DNA PCO) - dry, in the form of a trace of a dried drop at the bottom of the test tube, which is F. tularensis DNA isolated from a bacterial suspension of a tularemia microbe with a concentration of 1×106 m.k./ml.
- Device Name (Russian)
- Набор реагентов для выявления ДНК возбудителя туляремии методом полимеразной цепной реакции с учетом результатов в режиме реального времени (ГенТул - индикация - РГФ) по ТУ 9398-049-01898109-2014 В составе: 1. ПЦР-смесь-1 - сухая, в виде сиреневатого осадка, содержащая: смесь двух праймеров (ЗАО "Синтол", Россия), каждый в концентрации 8 пмоль/л; зонда (ЗАО "Синтол", Россия) в концентрации 4 пмоль/л, смесь дезоксинуклеозидтрифосфатов (дНТФ) - дАТФ, дГТФ, дЦТФ, дТТФ (ЗАО "Синтол", Россия), каждый в концентрации 1 ммоль/л; натрия азида ("Amresco", США) - 3 ммоль/л; 2. ПЦР-смесь-РГФ - прозрачная фиолетовая жидкость, содержащая Трис-HCl - 125 ммоль/л, pH 8.8 при 25°C (ЗАО "Синтол", Россия); калия хлорид (ЗАО "Синтол", Россия) - 125 ммоль/л; магния хлорид (ЗАО "Синтол", Россия) - 5,0 ммоль/л; Тween-20 (ЗАО "Синтол", Россия) - 0,05 ммоль/л, глицерин ("Amresco", США) - 17 ммоль/л, натрия азида ("Amresco", США) - 3,75 ммоль/л; 3. Taq ДНК-полимераза - Syn Taq ДНК-полимераза с ингибирующими активность фермента ан-тителами, прозрачная бесцветная жидкость (ЗАО "Синтол", Россия) - 5 ед/мкл; 4. Растворитель - прозрачная бесцветная жидкость, представляющая собой Н2О, свободную от нуклеаз ("Fermentas", США); 5. ТЕ-буфер - прозрачная бесцветная жидкость, содержащая Трис-HCl ("Amresco", США) - 10 ммоль; Na2-ЭДТА ("Amresco", США) - 1 ммоль; 6. Положительный контрольный образец ДНК F. tularensis (ПКО ДНК F. tularensis) - сухой, в виде следа от высушенной капли на дне пробирки, представляющая собой ДНК F. tularensis, выделенную из бактериальной суспензии туляремийного микроба с концентрацией 1×106 м.к./мл.
- Device Type (English)
- N/A
- Device Type (Russian)
- 139940
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 65967.0
- Registration Number
- РЗН 2015/3347
- 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 Reagent kit for the detection of DNA of the tularemia pathogen by polymerase chain reaction taking into account the results in real time (GenTool - indication - RGF) according to TU 9398-049-01898109-2014 Includes: 1. PCR-mixture-1 - dry, in the form of a lilac sediment, containing: a mixture of two primers (CJSC "Synthol", Russia), each in a concentration of 8 pmol/l; probe (CJSC "Synthol", Russia) at a concentration of 4 pmol/l, a mixture of deoxynucleoside triphosphates (dNTP) - dATP, dGTP, dCTP, dTTP (CJSC "Synthol", Russia), each at a concentration of 1 mmol/l; sodium azide (Amresco, USA) - 3 mmol/l; 2. PCR-mixture-RGF - transparent violet liquid containing Tris-HCl - 125 mmol/l, pH 8.8 at 25°C (CJSC "Synthol", Russia); potassium chloride (CJSC "Synthol", Russia) - 125 mmol/l; magnesium chloride (CJSC "Synthol", Russia) - 5.0 mmol/l; Tween-20 (CJSC "Synthol", Russia) - 0.05 mmol/l, glycerin ("Amresco", USA) - 17 mmol/l, sodium azide ("Amresco", USA) - 3.75 mmol/l; 3. Taq DNA polymerase - Syn Taq DNA polymerase with enzyme inhibitors, transparent colorless liquid (CJSC "Synthol", Russia) - 5 units/μl; 4. Solvent - a clear, colorless liquid that is H2O, free of nucleases ("Fermentas", USA); 5. TE-buffer - clear colorless liquid containing Tris-HCl ("Amresco", USA) - 10 mmol; Na2-EDTA ("Amresco", USA) - 1 mmol; 6. Positive F. tularensis DNA control sample (F. TULARENSIS DNA PCO) - dry, in the form of a trace of a dried drop at the bottom of the test tube, which is F. tularensis DNA isolated from a bacterial suspension of a tularemia microbe with a concentration of 1×106 m.k./ml. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2015/3347 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.