Reagent kit for the extraction of DNA/RNA from human biological material and ixodid ticks (NK-K (R)) according to TU 21.20.23-037-19926214-2023 In versions: I. Form 1, consisting of: 1. Cartridge with reagents NK-K (R) - 2 pcs.: a. Buffer F1 - 0.40 ml x rows A, E. b. MEP reagent - 0.30 ml x rows B, F. c. Buffer F2 - 0.70 ml x rows C, G. d. Buffer F3(R) -1.10 ml x rows D, H. 2. Disposable tips - 48 pcs. 3. Disposable tubes - 48 pcs. 4. Films for cartridge - 4 pcs. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. II. Form 2, consisting of: 1. F1 Buffer - 48.0 ml x 1 vial. 2. MR reagent - 0.96 ml x 1 test tube. 3. F2 Buffer - 48.0 ml x 1 vial. 4. F3(R) Buffer - 106.0 ml x 1 vial. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc in paper form. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. 8. Extraction protocol "NK-K-KF" - 1 pc. in electronic form at the address: http://www.amplitech.ru/resources/.
Russia·152850·LLC "Amplitek"·Registered May 13, 2024·Class 2b- Device Name (English)
- Reagent kit for the extraction of DNA/RNA from human biological material and ixodid ticks (NK-K (R)) according to TU 21.20.23-037-19926214-2023 In versions: I. Form 1, consisting of: 1. Cartridge with reagents NK-K (R) - 2 pcs.: a. Buffer F1 - 0.40 ml x rows A, E. b. MEP reagent - 0.30 ml x rows B, F. c. Buffer F2 - 0.70 ml x rows C, G. d. Buffer F3(R) -1.10 ml x rows D, H. 2. Disposable tips - 48 pcs. 3. Disposable tubes - 48 pcs. 4. Films for cartridge - 4 pcs. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. II. Form 2, consisting of: 1. F1 Buffer - 48.0 ml x 1 vial. 2. MR reagent - 0.96 ml x 1 test tube. 3. F2 Buffer - 48.0 ml x 1 vial. 4. F3(R) Buffer - 106.0 ml x 1 vial. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc in paper form. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. 8. Extraction protocol "NK-K-KF" - 1 pc. in electronic form at the address: http://www.amplitech.ru/resources/.
- Device Name (Russian)
- Набор реагентов для экстракции ДНК/РНК из биологического материала человека и иксодовых клещей (НК-К (R)) по ТУ 21.20.23-037-19926214-2023 в вариантах исполнения: I. Форма 1, в составе: 1. Картридж с реагентами НК-К (R) - 2 шт.: a. Буфер F1 - 0,40 мл х ряды А, Е. b. Реагент МЕР - 0,30 мл х ряды В, F. c. Буфер F2 - 0,70 мл х ряды С, G. d. Буфер F3(R) -1,10 мл х ряды D, Н. 2. Одноразовые наконечники - 48 шт. 3. Одноразовые пробирки - 48 шт. 4. Плёнки для картриджа - 4 шт. 5. Инструкция по применению - 1 шт. В бумажном виде и электронном виде по адресу: http://www.amplitech.ru/resources/. 6. Краткое руководство - 1 шт. 7. Паспорт - 1 шт. В электронном виде по адресу: http://www.amplitech.ru/quality/. II. Форма 2, в составе: 1. Буфер F1 - 48,0 мл х 1 флакон. 2. Реагент МР - 0,96 мл х 1 пробирка. 3. Буфер F2 - 48,0 мл х 1 флакон. 4. Буфер F3(R) - 106,0 мл х 1 флакон. 5. Инструкция по применению - 1 шт. В бумажном виде и электронном виде по адресу: http://www.amplitech.ru/resources/. 6. Краткое руководство - 1 шт. В бумажном виде. 7. Паспорт - 1 шт. В электронном виде по адресу: http://www.amplitech.ru/quality/. 8. Протокол экстракции «NK-K-KF» - 1 шт. В электронном виде по адресу: http://www.amplitech.ru/resources/.
- Device Type (English)
- N/A
- Device Type (Russian)
- 152850
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 76648.0
- Registration Number
- РЗН 2024/22613
- Registration Date
- May 13, 2024
- Manufacturer Name (English)
- LLC "Amplitek"
- Manufacturer Name (Russian)
- ООО "Амплитек"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- LLC "Amplitek", Russia, 109235, Moscow, 1st Kuryanovskaya str., 34, bldg. 8, fl. 1, room. II
- Legal Address (Russian)
- ООО "Амплитек", Россия, 109235, г. Москва, ул. 1-я Курьяновская, д. 34, стр. 8, эт. 1, помещ. II
- Manufacturing Address
- 109235, Россия, Москва, ул. 1-я Курьяновская, д. 34, стр. 8, эт. 1, помещ. II, ком. 42
Access comprehensive regulatory information for Reagent kit for the extraction of DNA/RNA from human biological material and ixodid ticks (NK-K (R)) according to TU 21.20.23-037-19926214-2023 In versions: I. Form 1, consisting of: 1. Cartridge with reagents NK-K (R) - 2 pcs.: a. Buffer F1 - 0.40 ml x rows A, E. b. MEP reagent - 0.30 ml x rows B, F. c. Buffer F2 - 0.70 ml x rows C, G. d. Buffer F3(R) -1.10 ml x rows D, H. 2. Disposable tips - 48 pcs. 3. Disposable tubes - 48 pcs. 4. Films for cartridge - 4 pcs. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. II. Form 2, consisting of: 1. F1 Buffer - 48.0 ml x 1 vial. 2. MR reagent - 0.96 ml x 1 test tube. 3. F2 Buffer - 48.0 ml x 1 vial. 4. F3(R) Buffer - 106.0 ml x 1 vial. 5. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 6. Quick Start Guide - 1 pc in paper form. 7. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. 8. Extraction protocol "NK-K-KF" - 1 pc. in electronic form at the address: http://www.amplitech.ru/resources/. 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 2024/22613 and manufactured by LLC "Amplitek". The device was registered on May 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.