Hepatitis C virus RNA (HCV) reagent kit by RT-PCR with real-time detection "AmpliPrime® HCV-test" according to TU 21.20.23-208-09286667-2023 Options: I. Dosage form 1 consisting of: 1. HCV PCR mixture - 0.6 ml x 2 tubes. 2. Buffer C - 0.3 mL x 2 tubes. 3. TG Reagent - 0.015ml x 2 tubes. 4. Taq polymerase - 0.06 mL x 2 tubes. 5. Revertase R - 0.015 ml x 2 tubes. 6. PCO-2 HCV - 0.025 ml x 4 test tubes. 7. VKO B - 0.6 ml x 2 test tubes. 8. OKO - 1.1 ml x 2 test tubes. 9. K- - 0.3 ml x 2 test tubes. II. Dosage form 2 consisting of: 1. HCV PCR mixture - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. Buffer D - 0.6 mL x 2 tubes. 3. TG Reagent - 0.015ml x 2 tubes. 4. Taq polymerase - 0.06 mL x 2 tubes. 5. Revertase R - 0.015 ml x 2 tubes. 6. PCO-2 HCV - 0.025 ml x 4 test tubes. 7. VKO B - 0.6 ml x 2 test tubes. 8. OKO - 1.1 ml x 2 test tubes. 9. K- - 0.3 ml x 2 test tubes. III. Dosage form 3 consisting of: 1. HCV PCR mixture - 0.01 ml x 100 tubes. 2. Buffer D - 0.6 mL x 2 tubes. 3. TG Reagent - 0.015ml x 2 tubes. 4. Taq polymerase - 0.06 mL x 2 tubes. 5. Revertase R - 0.015 ml x 2 tubes. 6. PCO-2 HCV - 0.025 ml x 4 test tubes. 7. VKO B - 0.6 ml x 2 test tubes. 8. OKO - 1.1 ml x 2 test tubes. 9. K- - 0.3 ml x 2 test tubes. IV. Dosage form 4 consisting of: 1. HCV Lyo PCR mixture - 96 tubes (12 strips of 8 tubes). 2. PKO-2 HCV Lyo - 4 test tubes. 3. VKO B Lyo - 2 test tubes. 4. OKO - 1.1 ml x 2 test tubes. 5. Diluent - 1.2 ml x 2 test tubes. Set set: 1. Reagent kit (dosage form 1, 2, 3 or 4). 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 3. A brief guide to the use of the kit in paper form. 4. A set of inserts for the set in paper form. 5. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru.
Russia·286220·LLC "NextBio"·Registered January 22, 2024·N/A- Device Name (English)
- Hepatitis C virus RNA (HCV) reagent kit by RT-PCR with real-time detection "AmpliPrime® HCV-test" according to TU 21.20.23-208-09286667-2023 Options: I. Dosage form 1 consisting of: 1. HCV PCR mixture - 0.6 ml x 2 tubes. 2. Buffer C - 0.3 mL x 2 tubes. 3. TG Reagent - 0.015ml x 2 tubes. 4. Taq polymerase - 0.06 mL x 2 tubes. 5. Revertase R - 0.015 ml x 2 tubes. 6. PCO-2 HCV - 0.025 ml x 4 test tubes. 7. VKO B - 0.6 ml x 2 test tubes. 8. OKO - 1.1 ml x 2 test tubes. 9. K- - 0.3 ml x 2 test tubes. II. Dosage form 2 consisting of: 1. HCV PCR mixture - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. Buffer D - 0.6 mL x 2 tubes. 3. TG Reagent - 0.015ml x 2 tubes. 4. Taq polymerase - 0.06 mL x 2 tubes. 5. Revertase R - 0.015 ml x 2 tubes. 6. PCO-2 HCV - 0.025 ml x 4 test tubes. 7. VKO B - 0.6 ml x 2 test tubes. 8. OKO - 1.1 ml x 2 test tubes. 9. K- - 0.3 ml x 2 test tubes. III. Dosage form 3 consisting of: 1. HCV PCR mixture - 0.01 ml x 100 tubes. 2. Buffer D - 0.6 mL x 2 tubes. 3. TG Reagent - 0.015ml x 2 tubes. 4. Taq polymerase - 0.06 mL x 2 tubes. 5. Revertase R - 0.015 ml x 2 tubes. 6. PCO-2 HCV - 0.025 ml x 4 test tubes. 7. VKO B - 0.6 ml x 2 test tubes. 8. OKO - 1.1 ml x 2 test tubes. 9. K- - 0.3 ml x 2 test tubes. IV. Dosage form 4 consisting of: 1. HCV Lyo PCR mixture - 96 tubes (12 strips of 8 tubes). 2. PKO-2 HCV Lyo - 4 test tubes. 3. VKO B Lyo - 2 test tubes. 4. OKO - 1.1 ml x 2 test tubes. 5. Diluent - 1.2 ml x 2 test tubes. Set set: 1. Reagent kit (dosage form 1, 2, 3 or 4). 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 3. A brief guide to the use of the kit in paper form. 4. A set of inserts for the set in paper form. 5. Quality certificate in electronic form on the official website of the Manufacturer: www.nextbio.ru.
- Device Name (Russian)
- Набор реагентов для выявления РНК вируса гепатита С (HСV) методом ОТ-ПЦР с детекцией в режиме "реального времени" "АмплиПрайм® HСV-тест" по ТУ 21.20.23-208-09286667-2023 варианты исполнения: I. Форма выпуска 1 в составе: 1. ПЦР-смесь HCV - 0,6 мл х 2 пробирки. 2. Буфер C - 0,3 мл х 2 пробирки. 3. Реагент TG - 0,015 мл х 2 пробирки. 4. Taq полимераза - 0,06 мл х 2 пробирки. 5. Ревертаза R - 0,015 мл х 2 пробирки. 6. ПКО-2 HCV - 0,025 мл х 4 пробирки. 7. ВКО В - 0,6 мл х 2 пробирки. 8. ОКО - 1,1 мл х 2 пробирки. 9. К- - 0,3 мл х 2 пробирки. II. Форма выпуска 2 в составе: 1. ПЦР-смесь HCV - 0,01 мл х 100 пробирок (12,5 стрипов по 8 пробирок). 2. Буфер D - 0,6 мл х 2 пробирки. 3. Реагент TG - 0,015 мл х 2 пробирки. 4. Taq полимераза - 0,06 мл х 2 пробирки. 5. Ревертаза R - 0,015 мл х 2 пробирки. 6. ПКО-2 HCV - 0,025 мл х 4 пробирки. 7. ВКО В - 0,6 мл х 2 пробирки. 8. ОКО - 1,1 мл х 2 пробирки. 9. К- - 0,3 мл х 2 пробирки. III. Форма выпуска 3 в составе: 1. ПЦР-смесь HCV - 0,01 мл х 100 пробирок. 2. Буфер D - 0,6 мл х 2 пробирки. 3. Реагент TG - 0,015 мл х 2 пробирки. 4. Taq полимераза - 0,06 мл х 2 пробирки. 5. Ревертаза R - 0,015 мл х 2 пробирки. 6. ПКО-2 HCV - 0,025 мл х 4 пробирки. 7. ВКО В - 0,6 мл х 2 пробирки. 8. ОКО - 1,1 мл х 2 пробирки. 9. К- - 0,3 мл х 2 пробирки. IV. Форма выпуска 4 в составе: 1. ПЦР-смесь HCV Lyo - 96 пробирок (12 стрипов по 8 пробирок). 2. ПКО-2 HCV Lyo - 4 пробирки. 3. ВКО В Lyo - 2 пробирки. 4. ОКО - 1,1 мл х 2 пробирки. 5. Разбавитель - 1,2 мл х 2 пробирки. Комплектность набора: 1. Набор реагентов (форма выпуска 1, 2, 3 или 4). 2. Инструкция по применению набора в электронном виде на официальном сайте Производителя: www.nextbio.ru. 3. Краткое руководство по применению набора в бумажном виде. 4. Комплект вкладышей к набору в бумажном виде. 5. Паспорт качества в электронном виде на официальном сайте Производителя: www.nextbio.ru.
- Device Type (English)
- N/A
- Device Type (Russian)
- 286220
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 74610.0
- Registration Number
- РЗН 2024/21922
- Registration Date
- January 22, 2024
- 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
Access comprehensive regulatory information for Hepatitis C virus RNA (HCV) reagent kit by RT-PCR with real-time detection "AmpliPrime® HCV-test" according to TU 21.20.23-208-09286667-2023 Options: I. Dosage form 1 consisting of: 1. HCV PCR mixture - 0.6 ml x 2 tubes. 2. Buffer C - 0.3 mL x 2 tubes. 3. TG Reagent - 0.015ml x 2 tubes. 4. Taq polymerase - 0.06 mL x 2 tubes. 5. Revertase R - 0.015 ml x 2 tubes. 6. PCO-2 HCV - 0.025 ml x 4 test tubes. 7. VKO B - 0.6 ml x 2 test tubes. 8. OKO - 1.1 ml x 2 test tubes. 9. K- - 0.3 ml x 2 test tubes. II. Dosage form 2 consisting of: 1. HCV PCR mixture - 0.01 ml x 100 tubes (12.5 strips of 8 tubes). 2. Buffer D - 0.6 mL x 2 tubes. 3. TG Reagent - 0.015ml x 2 tubes. 4. Taq polymerase - 0.06 mL x 2 tubes. 5. Revertase R - 0.015 ml x 2 tubes. 6. PCO-2 HCV - 0.025 ml x 4 test tubes. 7. VKO B - 0.6 ml x 2 test tubes. 8. OKO - 1.1 ml x 2 test tubes. 9. K- - 0.3 ml x 2 test tubes. III. Dosage form 3 consisting of: 1. HCV PCR mixture - 0.01 ml x 100 tubes. 2. Buffer D - 0.6 mL x 2 tubes. 3. TG Reagent - 0.015ml x 2 tubes. 4. Taq polymerase - 0.06 mL x 2 tubes. 5. Revertase R - 0.015 ml x 2 tubes. 6. PCO-2 HCV - 0.025 ml x 4 test tubes. 7. VKO B - 0.6 ml x 2 test tubes. 8. OKO - 1.1 ml x 2 test tubes. 9. K- - 0.3 ml x 2 test tubes. IV. Dosage form 4 consisting of: 1. HCV Lyo PCR mixture - 96 tubes (12 strips of 8 tubes). 2. PKO-2 HCV Lyo - 4 test tubes. 3. VKO B Lyo - 2 test tubes. 4. OKO - 1.1 ml x 2 test tubes. 5. Diluent - 1.2 ml x 2 test tubes. Set set: 1. Reagent kit (dosage form 1, 2, 3 or 4). 2. Instructions for use of the kit in electronic form on the official website of the Manufacturer: www.nextbio.ru. 3. A brief guide to the use of the kit in paper form. 4. A set of inserts for the set in paper form. 5. 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 medical device is registered under Roszdravnadzor registration number РЗН 2024/21922 and manufactured by LLC "NextBio". The device was registered on January 22, 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.