Reagent kit for genotyping of hepatitis C virus by multiplex RT-PCR-RV "HERA-S-GEN-test" according to TU 21.20.23-022-97638376-2020 Options: I. Configuration form "HEPA-C-GEN-test-A", consisting of: 1. "HEPA-C-GEN-test" reagent kit, consisting of: 1.1. RT-PCR buffer: 1 tube, 480 μL. 1.2. Oligonucleotide A mixture: 1 tube, 1440 μl. 1.3. PKO: 1 tube, 160 μl. 1.4. OKO: 2 test tubes, 1600 μl each. 1.5. VKO: 1 test tube, 950 μl. 2. Instructions for use - 1 pc. 3. Quality passport - 1 pc. per batch. II. Configuration form "HEPA-C-GEN-test-AB", consisting of: 1. "HEPA-C-GEN-test" reagent kit, consisting of: 1.1. RT-PCR buffer: 1 tube, 960 μL. 1.2. Oligonucleotide A mixture: 1 tube, 1440 μl. 1.3. Mixture of oligonucleotides B: 1 tube, 1440 μl. 1.4. PKO: 1 tube, 320 μl. 1.5. OKO: 4 test tubes, 1600 μl each. 1.6. ECP: 1 tube, 930 μl. 2. Instructions for use - 1 pc. 3. Quality passport - 1 pc. per batch.
Russia·314670·LLC "TestGen"·Registered December 20, 2023·N/A- Device Name (English)
- Reagent kit for genotyping of hepatitis C virus by multiplex RT-PCR-RV "HERA-S-GEN-test" according to TU 21.20.23-022-97638376-2020 Options: I. Configuration form "HEPA-C-GEN-test-A", consisting of: 1. "HEPA-C-GEN-test" reagent kit, consisting of: 1.1. RT-PCR buffer: 1 tube, 480 μL. 1.2. Oligonucleotide A mixture: 1 tube, 1440 μl. 1.3. PKO: 1 tube, 160 μl. 1.4. OKO: 2 test tubes, 1600 μl each. 1.5. VKO: 1 test tube, 950 μl. 2. Instructions for use - 1 pc. 3. Quality passport - 1 pc. per batch. II. Configuration form "HEPA-C-GEN-test-AB", consisting of: 1. "HEPA-C-GEN-test" reagent kit, consisting of: 1.1. RT-PCR buffer: 1 tube, 960 μL. 1.2. Oligonucleotide A mixture: 1 tube, 1440 μl. 1.3. Mixture of oligonucleotides B: 1 tube, 1440 μl. 1.4. PKO: 1 tube, 320 μl. 1.5. OKO: 4 test tubes, 1600 μl each. 1.6. ECP: 1 tube, 930 μl. 2. Instructions for use - 1 pc. 3. Quality passport - 1 pc. per batch.
- Device Name (Russian)
- Набор реагентов для генотипирования вируса гепатита С методом мультиплексной ОТ-ПЦР-РВ "НЕРА-С-ГЕН-тест" по ТУ 21.20.23-022-97638376-2020 варианты исполнения: I. Форма комплектации «HEPA-C-ГЕН-тест-A», в составе: 1. Набор реагентов «HEPA-C-ГЕН-тест», в составе: 1.1. ОТ-ПЦР-буфер: 1 пробирка, 480 мкл. 1.2. Смесь олигонуклеотидов А: 1 пробирка, 1440 мкл. 1.3. ПКО: 1 пробирка, 160 мкл. 1.4. ОКО: 2 пробирки, по 1600 мкл. 1.5. ВКО: 1 пробирка, 950 мкл. 2. Инструкция по применению - 1 шт. 3. Паспорт качества - 1 шт. на партию. II. Форма комплектации «HEPA-C-ГЕН-тест-AB», в составе: 1. Набор реагентов «HEPA-C-ГЕН-тест», в составе: 1.1. ОТ-ПЦР-буфер: 1 пробирка, 960 мкл. 1.2. Смесь олигонуклеотидов А: 1 пробирка, 1440 мкл. 1.3. Смесь олигонуклеотидов В: 1 пробирка, 1440 мкл. 1.4. ПКО: 1 пробирка, 320 мкл. 1.5. ОКО: 4 пробирки, по 1600 мкл. 1.6. ВКО: 1 пробирка, 930 мкл. 2. Инструкция по применению - 1 шт. 3. Паспорт качества - 1 шт. на партию.
- Device Type (English)
- N/A
- Device Type (Russian)
- 314670
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 75758.0
- Registration Number
- РЗН 2022/18556
- Registration Date
- December 20, 2023
- Manufacturer Name (English)
- LLC "TestGen"
- Manufacturer Name (Russian)
- ООО "ТестГен"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. TestGen LLC, Russia, 432072, Ulyanovsk, 44th Inzhenerny proezd, 9, pomeshch. 35, 36, 37. 2. NPP Biosfera LLC, 96 Vernadskogo Ave., Moscow, 119571, Russia. 3, 4, 5, 7, 8.
- Legal Address (Russian)
- 1. ООО "ТестГен", Россия, 432072, г. Ульяновск, 44-й Инженерный пр-д, д. 9, помещ. 35, 36, 37. 2. ООО "НПП Биосфера", Россия, 119571, г. Москва, пр-кт Вернадского, д. 96, помещ. 3, 4, 5, 7, 8.
- Manufacturing Address
- 432072, Россия, г. Ульяновск, 44-й Инженерный пр-д, д. 9, офис 13
Access comprehensive regulatory information for Reagent kit for genotyping of hepatitis C virus by multiplex RT-PCR-RV "HERA-S-GEN-test" according to TU 21.20.23-022-97638376-2020 Options: I. Configuration form "HEPA-C-GEN-test-A", consisting of: 1. "HEPA-C-GEN-test" reagent kit, consisting of: 1.1. RT-PCR buffer: 1 tube, 480 μL. 1.2. Oligonucleotide A mixture: 1 tube, 1440 μl. 1.3. PKO: 1 tube, 160 μl. 1.4. OKO: 2 test tubes, 1600 μl each. 1.5. VKO: 1 test tube, 950 μl. 2. Instructions for use - 1 pc. 3. Quality passport - 1 pc. per batch. II. Configuration form "HEPA-C-GEN-test-AB", consisting of: 1. "HEPA-C-GEN-test" reagent kit, consisting of: 1.1. RT-PCR buffer: 1 tube, 960 μL. 1.2. Oligonucleotide A mixture: 1 tube, 1440 μl. 1.3. Mixture of oligonucleotides B: 1 tube, 1440 μl. 1.4. PKO: 1 tube, 320 μl. 1.5. OKO: 4 test tubes, 1600 μl each. 1.6. ECP: 1 tube, 930 μl. 2. Instructions for use - 1 pc. 3. Quality passport - 1 pc. per batch. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2022/18556 and manufactured by LLC "TestGen". The device was registered on December 20, 2023.
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.