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. - Roszdravnadzor Registration РЗН 2015/3347

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.