Reagent kit for qualitative determination of Aspergillus niger DNA by isothermal amplification (IT) AmpliSens® AN-IT, TU 21.20.23-458-01897593-2023 Composed of: I. Form IT-50, consisting of: 1. IT-mix-AN 0.35 ml x 1 pc. 2. IT-mix-H 0.35 ml x 1 pc. 3. C+ IT-AN 0.1ml x 1pc 4. C-- 1.0 ml x 2 pcs. 5. IC 0.5ml x 1pc 6. Software on electronic media or on the Manufacturer's website (www.amplisens.ru): - AmpliSens® AN-IT Soft software version 1 - 1 pc.; - Operator's manual 1 pc. 7. 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 Reagent Kit 1 pc.
Russia·347540·Central Research Institute of Epidemiology of Rospotrebnadzor·Registered August 13, 2024·Class 2b- Device Name (English)
- Reagent kit for qualitative determination of Aspergillus niger DNA by isothermal amplification (IT) AmpliSens® AN-IT, TU 21.20.23-458-01897593-2023 Composed of: I. Form IT-50, consisting of: 1. IT-mix-AN 0.35 ml x 1 pc. 2. IT-mix-H 0.35 ml x 1 pc. 3. C+ IT-AN 0.1ml x 1pc 4. C-- 1.0 ml x 2 pcs. 5. IC 0.5ml x 1pc 6. Software on electronic media or on the Manufacturer's website (www.amplisens.ru): - AmpliSens® AN-IT Soft software version 1 - 1 pc.; - Operator's manual 1 pc. 7. 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 Reagent Kit 1 pc.
- Device Name (Russian)
- Набор реагентов для качественного определения ДНК Aspergillus niger методом изотермической амплификации (ИТ) AmpliSens® AN-IT, ТУ 21.20.23-458-01897593-2023 в составе: I. Форма IT-50, в составе: 1. IT-mix-AN 0,35 мл х 1 шт. 2. IT-mix-H 0,35 мл х 1 шт. 3. C+ IT-AN 0,1 мл х 1 шт. 4. С-- 1,0 мл х 2 шт. 5. IC 0,5 мл х 1 шт. 6. Программное обеспечение на электронном носителе или на сайте Изготовителя (www.amplisens.ru): - программное обеспечение AmpliSens® AN-IT Soft версия 1 - 1 шт.; - руководство оператора 1 шт. 7. 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)
- 347540
- Risk Class
- Class 2b
- OKPD Code
- 20.59.52.195
- Registry Key
- 80937.0
- Registration Number
- РЗН 2024/23347
- Registration Date
- August 13, 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, г. Москва, ул Новогиреевская, д. 3а. 2. ФБУН ЦНИИ Эпидемиологии Роспотребнадзора, Россия, 111123, г. 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 determination of Aspergillus niger DNA by isothermal amplification (IT) AmpliSens® AN-IT, TU 21.20.23-458-01897593-2023 Composed of: I. Form IT-50, consisting of: 1. IT-mix-AN 0.35 ml x 1 pc. 2. IT-mix-H 0.35 ml x 1 pc. 3. C+ IT-AN 0.1ml x 1pc 4. C-- 1.0 ml x 2 pcs. 5. IC 0.5ml x 1pc 6. Software on electronic media or on the Manufacturer's website (www.amplisens.ru): - AmpliSens® AN-IT Soft software version 1 - 1 pc.; - Operator's manual 1 pc. 7. 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 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 2024/23347 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.