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/.
Russia·350620·LLC "Amplitek"·Registered May 02, 2024·Class 2b- Device Name (English)
- 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/.
- Device Name (Russian)
- Набор реагентов для качественного определения РНК/ДНК возбудителей инфекций, передающихся человеку иксодовыми клещами, Tick-borne encephalitis virus, Borrelia burgdorferi s.l., Anaplasma phagocytophilum, Ehrlichia chaffeensis l Ehrlichia muris методом ОТ-ПЦР/ПЦР с детекцией в режиме "реального времени" (Amplitech TBI (R)) по ТУ 21.20.23-038-19926214-2024 формы выпуска: I. Форма 1, в составе: 1. Планшет с реагентами TBI (R) - 1 шт. - Смесь TBI (R)-1 - ряды А, С, Е, G; - Смесь TBI (R)-2 - ряды В, D, F, Н. 2. Плёнки для планшета - 2 шт. 3. ВК - 0,96 мл х 1 пробирка. 4. ОК - 0,8 мл х 1 пробирка. 5. ПК Т - 0,8 мл х 1 пробирка. 6. Инструкция по применению - 1 шт. В бумажном виде и электронном виде по адресу: http://www.amplitech.ru/resources/. 7. Краткое руководство - 1 шт. 8. Паспорт - 1 шт. В электронном виде по адресу: http://www.amplitech.ru/quality/. II. Форма 2, в составе: 1. Смесь TBI (RW)-1 - 0,96 мл х 1 пробирка. 2. Смесь TBI (RW)-2 - 0,96 мл х 1 пробирка. 3. ВК - 0,96 мл х 1 пробирка. 4. ОК - 0,8 мл х 1 пробирка. 5. ПК Т - 0,8 мл х 1 пробирка. 6. Инструкция по применению - 1 шт. В бумажном виде и электронном виде по адресу: http://www.amplitech.ru/resources/. 7. Краткое руководство - 1 шт. в бумажном виде. 8. Паспорт - 1 шт. В электронном виде по адресу: http://www.amplitech.ru/quality/.
- Device Type (English)
- N/A
- Device Type (Russian)
- 350620
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 76637.0
- Registration Number
- РЗН 2024/22555
- Registration Date
- May 02, 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 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.