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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. - Roszdravnadzor Registration РЗН 2023/21336

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.

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РЗН 2023/21336
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.
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.
Roszdravnadzor Registration Number: РЗН 2023/21336
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Device Information
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
Registration Information
Registry Key
75797.0
Registration Number
РЗН 2023/21336
Registration Date
December 20, 2023
Manufacturer Information
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