Reagent kit for the qualitative determination of RNA/DNA pathogens of infections transmitted to humans by ixodid ticks, Tick-borne encephalitis virus, Borrelia burgdorferi s.l., Anaplasma phagocytophilum, Ehrlichia chaffeensis l Ehrlichia muris by RT-PCR/PCR with "real-time" detection (Amplitech TBI (R)) according to TU 21.20.23-038-19926214-2024 Dosage forms: I. Form 1, consisting of: 1. Plate with TBI (R) reagents - 1 pc. - TBI(R)-1 mixture - rows A, C, E, G; - TBI(R)-2 mixture - rows B, D, F, H. 2. Films for the tablet - 2 pcs. 3. VK - 0.96 ml x 1 tube. 4. OK - 0.8 ml x 1 tube. 5. PC T - 0.8 ml x 1 tube. 6. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 7. Quick Start Guide - 1 pc. 8. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. II. Form 2, consisting of: 1. TBI(RW)-1 mixture - 0.96 mL x 1 tube. 2. TBI (RW)-2 mixture - 0.96 mL x 1 tube. 3. VK - 0.96 ml x 1 tube. 4. OK - 0.8 ml x 1 tube. 5. PC T - 0.8 ml x 1 tube. 6. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 7. Quick Start Guide - 1 pc in paper form. 8. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. - Roszdravnadzor Registration РЗН 2024/22555

Access comprehensive regulatory information for Reagent kit for the qualitative determination of RNA/DNA pathogens of infections transmitted to humans by ixodid ticks, Tick-borne encephalitis virus, Borrelia burgdorferi s.l., Anaplasma phagocytophilum, Ehrlichia chaffeensis l Ehrlichia muris by RT-PCR/PCR with "real-time" detection (Amplitech TBI (R)) according to TU 21.20.23-038-19926214-2024 Dosage forms: I. Form 1, consisting of: 1. Plate with TBI (R) reagents - 1 pc. - TBI(R)-1 mixture - rows A, C, E, G; - TBI(R)-2 mixture - rows B, D, F, H. 2. Films for the tablet - 2 pcs. 3. VK - 0.96 ml x 1 tube. 4. OK - 0.8 ml x 1 tube. 5. PC T - 0.8 ml x 1 tube. 6. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 7. Quick Start Guide - 1 pc. 8. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. II. Form 2, consisting of: 1. TBI(RW)-1 mixture - 0.96 mL x 1 tube. 2. TBI (RW)-2 mixture - 0.96 mL x 1 tube. 3. VK - 0.96 ml x 1 tube. 4. OK - 0.8 ml x 1 tube. 5. PC T - 0.8 ml x 1 tube. 6. Instructions for use - 1 pc. in paper form and in electronic form at the address: http://www.amplitech.ru/resources/. 7. Quick Start Guide - 1 pc in paper form. 8. Passport - 1 pc. in electronic form at the address: http://www.amplitech.ru/quality/. 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 2024/22555 and manufactured by LLC "Amplitek". The device was registered on May 02, 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.