Pure Global

AmpliSens® IBV-IT Reagent Kit for Detection of Influenza B Virus RNA by Reverse Transcription and Isothermal Amplification (RT-IT) , forms of configuration: 1. Form IT-200, consisting of: - IT-mix-IBV - 1.0 ml × 1 pc.; - IT-mix-E - 1.0 ml × 1 pc.; - C+ IT-IBV - 0.1 ml × 1 pc.; - C- - 1.0 ml × 2 pcs. 2. Software on electronic media or on the Manufacturer's website (www.amplisens.ru): - AmpliSens® IBV-IT Soft software version 1 - 1 pc.; - Operator's manual - 1 pc. 3. Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - 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. - Roszdravnadzor Registration РЗН 2024/23374

Access comprehensive regulatory information for AmpliSens® IBV-IT Reagent Kit for Detection of Influenza B Virus RNA by Reverse Transcription and Isothermal Amplification (RT-IT) , forms of configuration: 1. Form IT-200, consisting of: - IT-mix-IBV - 1.0 ml × 1 pc.; - IT-mix-E - 1.0 ml × 1 pc.; - C+ IT-IBV - 0.1 ml × 1 pc.; - C- - 1.0 ml × 2 pcs. 2. Software on electronic media or on the Manufacturer's website (www.amplisens.ru): - AmpliSens® IBV-IT Soft software version 1 - 1 pc.; - Operator's manual - 1 pc. 3. Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - 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. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number РЗН 2024/23374 and manufactured by Central Research Institute of Epidemiology of Rospotrebnadzor. The device was registered on August 13, 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.

Free Database
Powered by Pure Global AI
Roszdravnadzor Official Data
Class 2b
РЗН 2024/23374
AmpliSens® IBV-IT Reagent Kit for Detection of Influenza B Virus RNA by Reverse Transcription and Isothermal Amplification (RT-IT) , forms of configuration: 1. Form IT-200, consisting of: - IT-mix-IBV - 1.0 ml × 1 pc.; - IT-mix-E - 1.0 ml × 1 pc.; - C+ IT-IBV - 0.1 ml × 1 pc.; - C- - 1.0 ml × 2 pcs. 2. Software on electronic media or on the Manufacturer's website (www.amplisens.ru): - AmpliSens® IBV-IT Soft software version 1 - 1 pc.; - Operator's manual - 1 pc. 3. Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - 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.
Набор реагентов для выявления РНК вируса гриппа В методом обратной транскрипции и изотермической амплификации (ОТ-ИТ) AmpliSens® IBV-IT , формы комплектации: 1. Форма IT-200, в составе: - IT-mix-IBV - 1,0 мл × 1 шт.; - IT-mix-E - 1,0 мл × 1 шт.; - С+ IT-IBV - 0,1 мл × 1 шт.; - С- - 1,0 мл × 2 шт. 2. Программное обеспечение на электронном носителе или на сайте Изготовителя (www.amplisens.ru): - Программное обеспечение AmpliSens® IBV-IT Soft версия 1 - 1 шт.; - Руководство оператора - 1 шт. 3. Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (www.amplisens.ru): - Инструкция по применению - 1 шт.; - Паспорт качества набора реагентов - 1 шт.; - Вкладыш к набору реагентов - 1 комплект; - Краткое руководство к набору реагентов - 1 шт.
Roszdravnadzor Registration Number: РЗН 2024/23374
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Information
Device Name (English)
AmpliSens® IBV-IT Reagent Kit for Detection of Influenza B Virus RNA by Reverse Transcription and Isothermal Amplification (RT-IT) , forms of configuration: 1. Form IT-200, consisting of: - IT-mix-IBV - 1.0 ml × 1 pc.; - IT-mix-E - 1.0 ml × 1 pc.; - C+ IT-IBV - 0.1 ml × 1 pc.; - C- - 1.0 ml × 2 pcs. 2. Software on electronic media or on the Manufacturer's website (www.amplisens.ru): - AmpliSens® IBV-IT Soft software version 1 - 1 pc.; - Operator's manual - 1 pc. 3. Operational documentation on paper and on the Manufacturer's website (www.amplisens.ru): - 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.
Device Name (Russian)
Набор реагентов для выявления РНК вируса гриппа В методом обратной транскрипции и изотермической амплификации (ОТ-ИТ) AmpliSens® IBV-IT , формы комплектации: 1. Форма IT-200, в составе: - IT-mix-IBV - 1,0 мл × 1 шт.; - IT-mix-E - 1,0 мл × 1 шт.; - С+ IT-IBV - 0,1 мл × 1 шт.; - С- - 1,0 мл × 2 шт. 2. Программное обеспечение на электронном носителе или на сайте Изготовителя (www.amplisens.ru): - Программное обеспечение AmpliSens® IBV-IT Soft версия 1 - 1 шт.; - Руководство оператора - 1 шт. 3. Эксплуатационная документация на бумажном носителе и на сайте Изготовителя (www.amplisens.ru): - Инструкция по применению - 1 шт.; - Паспорт качества набора реагентов - 1 шт.; - Вкладыш к набору реагентов - 1 комплект; - Краткое руководство к набору реагентов - 1 шт.
Device Type (English)
N/A
Device Type (Russian)
295680
Risk Class
Class 2b
OKPD Code
20.59.52.195
Registration Information
Registry Key
80142.0
Registration Number
РЗН 2024/23374
Registration Date
August 13, 2024
Manufacturer Information
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