Reagent kit for the detection of hepatitis B virus (HBV) DNA in clinical material by polymerase chain reaction (PCR) with hybridization-fluorescence detection "AmpliSense® HBV-FL" Forms of configuration: Form 4: "PCR kit" variant FRT: "PCR kit" version FRT - a set of reagents for amplification of a section of hepatitis B virus (HBV) DNA with hybridization-fluorescence detection in "real time" - includes: 1) PCR mixture-1-FL HBV - 4 tubes (0.3 ml); 2) PCR-buffer-B - 4 tubes (0.2 ml); 3) Polymerase (TaqF) - 4 tubes (0.02 ml); 4) KB2 HBV - 4 tubes (0.1 mL); 5) Elution buffer - 2 tubes (1.2 ml); 6) OKO - 4 tubes (1.2 ml); 7) PCO-1-HBV - 4 tubes (0.06 ml); 8) VKO STI-87 - 4 tubes (0.28 ml); The software, including the operator's manual, can be provided on an electronic data carrier or presented on the official website of the manufacturer (authorized person of the manufacturer): - AmpliSens® HBV Soft software version 1 - 1 pc. - Operator's manual - 1 pc. Operational documentation can be made in paper form and presented on the official website of the manufacturer (authorized person of the manufacturer): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. Technical documentation: TU 9398-030-01897593-2012.
Russia·286800·Central Research Institute of Epidemiology of Rospotrebnadzor·Registered June 06, 2024·N/A- Device Name (English)
- Reagent kit for the detection of hepatitis B virus (HBV) DNA in clinical material by polymerase chain reaction (PCR) with hybridization-fluorescence detection "AmpliSense® HBV-FL" Forms of configuration: Form 4: "PCR kit" variant FRT: "PCR kit" version FRT - a set of reagents for amplification of a section of hepatitis B virus (HBV) DNA with hybridization-fluorescence detection in "real time" - includes: 1) PCR mixture-1-FL HBV - 4 tubes (0.3 ml); 2) PCR-buffer-B - 4 tubes (0.2 ml); 3) Polymerase (TaqF) - 4 tubes (0.02 ml); 4) KB2 HBV - 4 tubes (0.1 mL); 5) Elution buffer - 2 tubes (1.2 ml); 6) OKO - 4 tubes (1.2 ml); 7) PCO-1-HBV - 4 tubes (0.06 ml); 8) VKO STI-87 - 4 tubes (0.28 ml); The software, including the operator's manual, can be provided on an electronic data carrier or presented on the official website of the manufacturer (authorized person of the manufacturer): - AmpliSens® HBV Soft software version 1 - 1 pc. - Operator's manual - 1 pc. Operational documentation can be made in paper form and presented on the official website of the manufacturer (authorized person of the manufacturer): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. Technical documentation: TU 9398-030-01897593-2012.
- Device Name (Russian)
- Набор реагентов для выявления ДНК вируса гепатита В (HВV) в клиническом материале методом полимеразной цепной реакции (ПЦР) с гибридизационно-флуоресцентной детекцией «АмплиСенс® HBV-FL» Формы комплектации: Форма 4: «ПЦР-комплект» вариант FRT: «ПЦР-комплект» вариант FRT - комплект реагентов для амплификации участка ДНК вируса гепатита B (HBV) с гибридизационно-флуоресцентной детекцией в режиме «реального времени» - включает: 1) ПЦР-смесь-1-FL HBV - 4 пробирки (0,3 мл); 2) ПЦР-буфер-B - 4 пробирки (0,2 мл); 3) Полимераза (TaqF) - 4 пробирки (0,02 мл); 4) KB2 HBV - 4 пробирки (0,1 мл); 5) Буфер для элюции - 2 пробирки (1,2 мл); 6) ОКО - 4 пробирки (1,2 мл); 7) ПКO-1-HBV - 4 пробирки (0,06 мл); 8) ВКО STI-87- 4 пробирки (0,28 мл); Программное обеспечение, включая руководство оператора, может быть предо-ставлено на электронном носителе информации или представлено на официальном сайте изготовителя (уполномоченного лица изготовителя): - Программное обеспечение AmpliSens® HBV Soft версия 1 - 1 шт. - Руководство оператора - 1 шт. Эксплуатационная документация может быть изготовлена в бумажном виде и представлена на официальном сайте изготовителя (уполномоченного лица изготовителя): - Инструкция по применению - 1 шт.; - Паспорт качества набора реагентов - 1 шт.; - Вкладыш к набору реагентов - 1 комплект; - Краткое руководство к набору реагентов - 1 шт. Техническая документация: ТУ 9398-030-01897593-2012.
- Device Type (English)
- N/A
- Device Type (Russian)
- 286800
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 79951.0
- Registration Number
- ФСР 2007/00585
- 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 the detection of hepatitis B virus (HBV) DNA in clinical material by polymerase chain reaction (PCR) with hybridization-fluorescence detection "AmpliSense® HBV-FL" Forms of configuration: Form 4: "PCR kit" variant FRT: "PCR kit" version FRT - a set of reagents for amplification of a section of hepatitis B virus (HBV) DNA with hybridization-fluorescence detection in "real time" - includes: 1) PCR mixture-1-FL HBV - 4 tubes (0.3 ml); 2) PCR-buffer-B - 4 tubes (0.2 ml); 3) Polymerase (TaqF) - 4 tubes (0.02 ml); 4) KB2 HBV - 4 tubes (0.1 mL); 5) Elution buffer - 2 tubes (1.2 ml); 6) OKO - 4 tubes (1.2 ml); 7) PCO-1-HBV - 4 tubes (0.06 ml); 8) VKO STI-87 - 4 tubes (0.28 ml); The software, including the operator's manual, can be provided on an electronic data carrier or presented on the official website of the manufacturer (authorized person of the manufacturer): - AmpliSens® HBV Soft software version 1 - 1 pc. - Operator's manual - 1 pc. Operational documentation can be made in paper form and presented on the official website of the manufacturer (authorized person of the manufacturer): - Instructions for use - 1 pc.; - Quality certificate of the reagent kit - 1 pc.; - Insert for the reagent kit - 1 set; - Quick start guide to the reagent kit - 1 pc. Technical documentation: TU 9398-030-01897593-2012. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФСР 2007/00585 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.