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/. - Roszdravnadzor Registration РЗН 2024/22613

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.