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
Russia·327670·Central Research Institute of Epidemiology of Rospotrebnadzor·Registered June 06, 2024·Class 2b- Device Name (English)
- 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
- Device Name (Russian)
- Набор реагентов для качественного и количественного определения ДНК вируса Эпштейна-Барр (EBV), цитомегаловируса человека (CMV) и вируса герпеса человека 6A/B (HHV6A/B) в биологическом материале методом полимеразной цепной реакции с гибридизационно-флуоресцентной детекцией в режиме "реального времени" "АмплиСенс® EBV/CMV/HHV6A/B-cкрин-FL" Форма 1: «ПЦР-комплект» вариант FRT-L-t Состав комплекта: - ПЦР-смесь EBV / CMV / HHV6 / Glob-Lyo × 96 шт.; - К- 0,5 мл × 1 шт.; - КSG1 0,5 мл × 1 шт.; - КSG2 0,5 мл × 1 шт.; - ОКО 1,2 мл × 4 шт.; - ПКО ДНК EBV / CMV / HHV6 и ДНК человека 0,5 мл × 1 шт.; - Электронный калькулятор на электронном носителе или сайте Изготовителя (www.amplisens.ru): - Электронный калькулятор на базе Microsoft® Excel «АмплиСенс® EBV / CMV / HHV6A/B-cкрин» - 1 шт. - Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (www.amplisens.ru): - Инструкция по применению - 1 шт.; - Паспорт качества - 1 шт.; - Вкладыш - 1 комплект; - Краткое руководство - 1 шт. Форма 2: «ПЦР-комплект» вариант FRT-100 FN: Состоит из 2 частей: 1. Часть 1 из 2. Состав: - К- 0,2 мл × 1 шт.; - КSG1 0,2 мл × 1 шт.; - КSG2 0,2 мл × 1 шт.; - ОКО 1,2 мл × 4 шт.; - ПКО ДНК EBV / CMV / HHV6 и ДНК человека 0,5 мл × 1 шт.; 2. Часть 2 из 2. Состав: - ПЦР-смесь-1-FRT EBV / CMV / HHV6 / Glob 0,6 мл × 2 шт.; - ПЦР-буфер-H 0,3 мл × 2 шт. - Электронный калькулятор на электронном носителе или сайте Изготовителя (www.amplisens.ru): - Электронный калькулятор на базе Microsoft® Excel «АмплиСенс® EBV / CMV / HHV6A/B-cкрин» - 1 шт. - Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (www.amplisens.ru): - Инструкция по применению - 1 шт.; - Паспорт качества - 1 шт.; - Вкладыш - 1 комплект; - Краткое руководство - 1 шт. Техническая документация: ТУ 9398-095-01897593-2012
- Device Type (English)
- N/A
- Device Type (Russian)
- 327670
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 79495.0
- Registration Number
- ФСР 2010/09502
- Registration Date
- June 06, 2024
- Manufacturer Name (English)
- Central Research Institute of Epidemiology of Rospotrebnadzor
- Manufacturer Name (Russian)
- ФБУН ЦНИИ Эпидемиологии Роспотребнадзора
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. Central Research Institute of Epidemiology of Rospotrebnadzor, Russia, 111123, Moscow, Novogireevskaya str., 3A. 2. Central Research Institute of Epidemiology of Rospotrebnadzor, Russia, 111123, Moscow, Novogireevskaya str., 3A, bldg. 6.
- Legal Address (Russian)
- 1. ФБУН ЦНИИ Эпидемиологии Роспотребнадзора, Россия, 111123, Москва, ул. Новогиреевская, д. 3А. 2. ФБУН ЦНИИ Эпидемиологии Роспотребнадзора, Россия, 111123, Москва, ул. Новогиреевская, д. 3А, стр. 6.
- Manufacturing Address
- 111123, Россия, Москва, ул. Новогиреевская, д. 3А
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.