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MagnoPrime® DrySpot reagent kit for human DNA extraction from dry blood spots and whole blood according to TU 21.20.23-219-09286667-2023 Composed of: 1. Reagent S1 - 46.0 ml x 1 vial. 2. L1 Buffer - 53.0 ml x 1 vial. 3. W21 Buffer - 75.0 ml x 2 vials. 4. W31 Buffer - 75.0 ml x 1 vial. 5. Buffer E1 - 15.0 ml x 1 vial. 6. MAP - 1.1 ml x 1 tube. 7. Reagent A - 1.1 ml x 1 tube. Set set: 1. A set of reagents. 2. Instructions for use of the kit in electronic form2 on the official website of the Manufacturer: www.nextbio.ru 3. A brief guide to the use of the kit in paper form. 4. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru - Roszdravnadzor Registration РЗН 2024/22489

Access comprehensive regulatory information for MagnoPrime® DrySpot reagent kit for human DNA extraction from dry blood spots and whole blood according to TU 21.20.23-219-09286667-2023 Composed of: 1. Reagent S1 - 46.0 ml x 1 vial. 2. L1 Buffer - 53.0 ml x 1 vial. 3. W21 Buffer - 75.0 ml x 2 vials. 4. W31 Buffer - 75.0 ml x 1 vial. 5. Buffer E1 - 15.0 ml x 1 vial. 6. MAP - 1.1 ml x 1 tube. 7. Reagent A - 1.1 ml x 1 tube. Set set: 1. A set of reagents. 2. Instructions for use of the kit in electronic form2 on the official website of the Manufacturer: www.nextbio.ru 3. A brief guide to the use of the kit in paper form. 4. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number РЗН 2024/22489 and manufactured by LLC "NextBio". The device was registered on April 23, 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.

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Roszdravnadzor Official Data
Class 2a
РЗН 2024/22489
MagnoPrime® DrySpot reagent kit for human DNA extraction from dry blood spots and whole blood according to TU 21.20.23-219-09286667-2023 Composed of: 1. Reagent S1 - 46.0 ml x 1 vial. 2. L1 Buffer - 53.0 ml x 1 vial. 3. W21 Buffer - 75.0 ml x 2 vials. 4. W31 Buffer - 75.0 ml x 1 vial. 5. Buffer E1 - 15.0 ml x 1 vial. 6. MAP - 1.1 ml x 1 tube. 7. Reagent A - 1.1 ml x 1 tube. Set set: 1. A set of reagents. 2. Instructions for use of the kit in electronic form2 on the official website of the Manufacturer: www.nextbio.ru 3. A brief guide to the use of the kit in paper form. 4. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru
Набор реагентов для экстракции ДНК человека из сухих пятен крови и цельной крови «МагноПрайм® DrySpot» по ТУ 21.20.23-219-09286667-2023 в составе: 1. Реагент S1 - 46,0 мл х 1 флакон. 2. Буфер L1 - 53,0 мл х 1 флакон. 3. Буфер W21 - 75,0 мл х 2 флакона. 4. Буфер W31 - 75,0 мл х 1 флакон. 5. Буфер Е1 - 15,0 мл х 1 флакон. 6. МГС - 1,1 мл х 1 пробирка. 7. Реагент А - 1,1 мл х 1 пробирка. Комплектность набора: 1. Набор реагентов. 2. Инструкция по применению набора в электронном виде2 на официальном сайте Производителя: www.nextbio.ru 3. Краткое руководство по применению набора в бумажном виде. 4. Паспорт качества в электронном виде на официальном сайте Производителя: www.nextbio.ru
Roszdravnadzor Registration Number: РЗН 2024/22489
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Device Information
Device Name (English)
MagnoPrime® DrySpot reagent kit for human DNA extraction from dry blood spots and whole blood according to TU 21.20.23-219-09286667-2023 Composed of: 1. Reagent S1 - 46.0 ml x 1 vial. 2. L1 Buffer - 53.0 ml x 1 vial. 3. W21 Buffer - 75.0 ml x 2 vials. 4. W31 Buffer - 75.0 ml x 1 vial. 5. Buffer E1 - 15.0 ml x 1 vial. 6. MAP - 1.1 ml x 1 tube. 7. Reagent A - 1.1 ml x 1 tube. Set set: 1. A set of reagents. 2. Instructions for use of the kit in electronic form2 on the official website of the Manufacturer: www.nextbio.ru 3. A brief guide to the use of the kit in paper form. 4. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru
Device Name (Russian)
Набор реагентов для экстракции ДНК человека из сухих пятен крови и цельной крови «МагноПрайм® DrySpot» по ТУ 21.20.23-219-09286667-2023 в составе: 1. Реагент S1 - 46,0 мл х 1 флакон. 2. Буфер L1 - 53,0 мл х 1 флакон. 3. Буфер W21 - 75,0 мл х 2 флакона. 4. Буфер W31 - 75,0 мл х 1 флакон. 5. Буфер Е1 - 15,0 мл х 1 флакон. 6. МГС - 1,1 мл х 1 пробирка. 7. Реагент А - 1,1 мл х 1 пробирка. Комплектность набора: 1. Набор реагентов. 2. Инструкция по применению набора в электронном виде2 на официальном сайте Производителя: www.nextbio.ru 3. Краткое руководство по применению набора в бумажном виде. 4. Паспорт качества в электронном виде на официальном сайте Производителя: www.nextbio.ru
Device Type (English)
N/A
Device Type (Russian)
152850
Risk Class
Class 2a
OKPD Code
21.20.23.110
Registration Information
Registry Key
79247.0
Registration Number
РЗН 2024/22489
Registration Date
April 23, 2024
Manufacturer Information
Manufacturer Name (English)
LLC "NextBio"
Manufacturer Name (Russian)
ООО "НекстБио"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
NextBio LLC, Russia, 111394, Moscow, Polimernaya str., 8, bldg. 2
Legal Address (Russian)
ООО "НекстБио", Россия, 111394, Москва, ул. Полимерная, д. 8, стр. 2
Manufacturing Address
111394, Россия, Москва, ул. Полимерная, д. 8, стр. 2