Reagent kit for qualitative and quantitative determination of DNA of Epstein-Barr virus (EBV), human cytomegalovirus (CMV) and human herpes virus 6A/B (HHV6A/B) in biological material by polymerase chain reaction with hybridization-fluorescence detection in "real time" "AmpliSense® EBV/CMV/HHV6A/B-screen-FL" Form 1: "PCR kit" variant FRT-L-t The kit includes: - PCR mixture EBV / CMV / HHV6 / Glob-Lyo × 96 pcs.; - K - 0.5 ml × 1 pc.; - KSG1 0.5 ml × 1 pc.; - КSG2 0.5 ml × 1 pc.; - OKO 1.2 ml × 4 pcs.; - PCO DNA EBV / CMV / HHV6 and human DNA 0.5 ml × 1 pc.; - Electronic calculator on electronic media or on the Manufacturer's website (www.amplisens.ru): - Electronic calculator based on Microsoft® Excel "AmpliSense® EBV / CMV / HHV6A / B-screen" - 1 pc. - Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - Instructions for use - 1 pc.; - Quality passport - 1 pc.; - Liner - 1 set; - Quick Start Guide - 1 pc. Form 2: "PCR kit" variant FRT-100 FN: It consists of 2 parts: 1. Part 1 of 2. Composition: - K - 0.2 ml × 1 pc.; - KSG1 0.2 ml × 1 pc.; - КSG2 0.2 ml × 1 pc.; - OKO 1.2 ml × 4 pcs.; - PCO DNA EBV / CMV / HHV6 and human DNA 0.5 ml × 1 pc.; 2. Part 2 of 2. Composition: - PCR mixture-1-FRT EBV / CMV / HHV6 / Glob 0.6 ml × 2 pcs.; - PCR buffer-H 0.3 ml × 2 pcs. - Electronic calculator on electronic media or on the Manufacturer's website (www.amplisens.ru): - Electronic calculator based on Microsoft® Excel "AmpliSense® EBV / CMV / HHV6A / B-screen" - 1 pc. - Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - Instructions for use - 1 pc.; - Quality passport - 1 pc.; - Liner - 1 set; - Quick Start Guide - 1 pc. Technical documentation: TU 9398-095-01897593-2012 - Roszdravnadzor Registration ФСР 2010/09502

Access comprehensive regulatory information for Reagent kit for qualitative and quantitative determination of DNA of Epstein-Barr virus (EBV), human cytomegalovirus (CMV) and human herpes virus 6A/B (HHV6A/B) in biological material by polymerase chain reaction with hybridization-fluorescence detection in "real time" "AmpliSense® EBV/CMV/HHV6A/B-screen-FL" Form 1: "PCR kit" variant FRT-L-t The kit includes: - PCR mixture EBV / CMV / HHV6 / Glob-Lyo × 96 pcs.; - K - 0.5 ml × 1 pc.; - KSG1 0.5 ml × 1 pc.; - КSG2 0.5 ml × 1 pc.; - OKO 1.2 ml × 4 pcs.; - PCO DNA EBV / CMV / HHV6 and human DNA 0.5 ml × 1 pc.; - Electronic calculator on electronic media or on the Manufacturer's website (www.amplisens.ru): - Electronic calculator based on Microsoft® Excel "AmpliSense® EBV / CMV / HHV6A / B-screen" - 1 pc. - Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - Instructions for use - 1 pc.; - Quality passport - 1 pc.; - Liner - 1 set; - Quick Start Guide - 1 pc. Form 2: "PCR kit" variant FRT-100 FN: It consists of 2 parts: 1. Part 1 of 2. Composition: - K - 0.2 ml × 1 pc.; - KSG1 0.2 ml × 1 pc.; - КSG2 0.2 ml × 1 pc.; - OKO 1.2 ml × 4 pcs.; - PCO DNA EBV / CMV / HHV6 and human DNA 0.5 ml × 1 pc.; 2. Part 2 of 2. Composition: - PCR mixture-1-FRT EBV / CMV / HHV6 / Glob 0.6 ml × 2 pcs.; - PCR buffer-H 0.3 ml × 2 pcs. - Electronic calculator on electronic media or on the Manufacturer's website (www.amplisens.ru): - Electronic calculator based on Microsoft® Excel "AmpliSense® EBV / CMV / HHV6A / B-screen" - 1 pc. - Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - Instructions for use - 1 pc.; - Quality passport - 1 pc.; - Liner - 1 set; - Quick Start Guide - 1 pc. Technical documentation: TU 9398-095-01897593-2012 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 2010/09502 and manufactured by Central Research Institute of Epidemiology of Rospotrebnadzor. The device was registered on June 06, 2024.

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.