Reagent kit for the isolation of DNA and RNA viruses from human blood plasma by the precipitating method "NK-Plasma-P" according to TU 21.20.23-056-97638376-2022 Composed of: 1. Lysis buffer: 1 vial, 45 ml. 2. Precipitation solution: 2 vials, 50 ml each. 3. Rinsing solution No1: 1 vial, 60 ml. 4. Rinsing solution No2: 1 bottle, 20 ml. 5. NA dissolution buffer: 2 vials, 10 ml each. 6. Proteinase K: 2 vials, 20 mg each. 7. Solution for diluting proteinase K: 2 test tubes, 1 ml each. The delivery set of the NK-Plasma-P reagent kit includes: - NK-Plasma-P reagent kit; - instructions for use - 1 pc.; - Quality passport - 1 pc. per batch.
Russia·152850·LLC "TestGen"·Registered December 20, 2023·N/A- Device Name (English)
- Reagent kit for the isolation of DNA and RNA viruses from human blood plasma by the precipitating method "NK-Plasma-P" according to TU 21.20.23-056-97638376-2022 Composed of: 1. Lysis buffer: 1 vial, 45 ml. 2. Precipitation solution: 2 vials, 50 ml each. 3. Rinsing solution No1: 1 vial, 60 ml. 4. Rinsing solution No2: 1 bottle, 20 ml. 5. NA dissolution buffer: 2 vials, 10 ml each. 6. Proteinase K: 2 vials, 20 mg each. 7. Solution for diluting proteinase K: 2 test tubes, 1 ml each. The delivery set of the NK-Plasma-P reagent kit includes: - NK-Plasma-P reagent kit; - instructions for use - 1 pc.; - Quality passport - 1 pc. per batch.
- Device Name (Russian)
- Набор реагентов для выделения ДНК и РНК вирусов из плазмы крови человека преципитирующим методом "НК-Плазма-П" по ТУ 21.20.23-056-97638376-2022 в составе: 1. Буфер для лизиса: 1 флакон, 45 мл. 2. Раствор для преципитации: 2 флакона, по 50 мл. 3. Раствор для промывки №1: 1 флакон, 60 мл. 4. Раствор для промывки №2: 1 флакон, 20 мл. 5. Буфер для растворения НК: 2 флакона, по 10 мл. 6. Протеиназа К: 2 флакона, по 20 мг. 7. Раствор для разведения протеиназы К: 2 пробирки, по 1 мл. В комплект поставки набора реагентов «НК-Плазма-П» входит: - набор реагентов «НК-Плазма-П»; - инструкция по применению - 1 шт.; - паспорт качества - 1 шт. на партию.
- Device Type (English)
- N/A
- Device Type (Russian)
- 152850
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 75797.0
- Registration Number
- РЗН 2023/21336
- Registration Date
- December 20, 2023
- Manufacturer Name (English)
- LLC "TestGen"
- Manufacturer Name (Russian)
- ООО "ТестГен"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. TestGen LLC, Russia, 432072, Ulyanovsk, 44th Inzhenerny proezd, 9, pomeshch. 35, 36, 37. 2. NPP Biosfera LLC, 96 Vernadskogo Ave., Moscow, 119571, Russia. 3, 4, 5, 7, 8.
- Legal Address (Russian)
- 1. ООО "ТестГен", Россия, 432072, г. Ульяновск, 44-й Инженерный пр-д, д. 9, помещ. 35, 36, 37. 2. ООО "НПП Биосфера", Россия, 119571, г. Москва, пр-кт Вернадского, д. 96, помещ. 3, 4, 5, 7, 8.
- Manufacturing Address
- 432072, Россия, г. Ульяновск, 44-й Инженерный пр-д, д. 9, офис 13
Access comprehensive regulatory information for Reagent kit for the isolation of DNA and RNA viruses from human blood plasma by the precipitating method "NK-Plasma-P" according to TU 21.20.23-056-97638376-2022 Composed of: 1. Lysis buffer: 1 vial, 45 ml. 2. Precipitation solution: 2 vials, 50 ml each. 3. Rinsing solution No1: 1 vial, 60 ml. 4. Rinsing solution No2: 1 bottle, 20 ml. 5. NA dissolution buffer: 2 vials, 10 ml each. 6. Proteinase K: 2 vials, 20 mg each. 7. Solution for diluting proteinase K: 2 test tubes, 1 ml each. The delivery set of the NK-Plasma-P reagent kit includes: - NK-Plasma-P reagent kit; - instructions for use - 1 pc.; - Quality passport - 1 pc. per batch. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2023/21336 and manufactured by LLC "TestGen". The device was registered on December 20, 2023.
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.