Reagent kit for qualitative and quantitative determination of hepatitis D virus RNA in human blood plasma samples by real-time polymerase chain reaction with reverse transcription hybridization-fluorescence detection (RT-PCR-RV) "HEP-test-Q" according to TU 21.20.23-020-97638376-2020 , consisting of: 1. RT-PCR buffer - 1 tube, 480 μL. 2. Oligonucleotide mixture - 1 test tube, 1440 μl. 3. PCO - 1 tube, 50 μl. 4. OKO - 1 test tube, 1000 μl. 5. VKO - 1 test tube, 950 μl. 6. KO-1 - 2 test tubes, 1500 μl each. 7. KO-2 - 2 test tubes, 1500 μl each. 8. Instructions for use - 1 pc. 9. Quality passport - 1 pc. per batch.
Russia·285280·LLC "TestGen"·Registered December 20, 2023·N/A- Device Name (English)
- Reagent kit for qualitative and quantitative determination of hepatitis D virus RNA in human blood plasma samples by real-time polymerase chain reaction with reverse transcription hybridization-fluorescence detection (RT-PCR-RV) "HEP-test-Q" according to TU 21.20.23-020-97638376-2020 , consisting of: 1. RT-PCR buffer - 1 tube, 480 μL. 2. Oligonucleotide mixture - 1 test tube, 1440 μl. 3. PCO - 1 tube, 50 μl. 4. OKO - 1 test tube, 1000 μl. 5. VKO - 1 test tube, 950 μl. 6. KO-1 - 2 test tubes, 1500 μl each. 7. KO-2 - 2 test tubes, 1500 μl each. 8. Instructions for use - 1 pc. 9. Quality passport - 1 pc. per batch.
- Device Name (Russian)
- Набор реагентов для качественного и количественного определения РНК вируса гепатита D в образцах плазмы крови человека методом полимеразной цепной реакции в реальном времени с гибридизационно-флуоресцентной детекцией с обратной транскрипцией (ОТ-ПЦР-РВ) "НЕРА-D-тест-Q" по ТУ 21.20.23-020-97638376-2020 , в составе: 1. ОТ-ПЦР-буфер - 1 пробирка, 480 мкл. 2. Смесь олигонуклеотидов - 1 пробирка, 1440 мкл. 3. ПКО - 1 пробирка, 50 мкл. 4. ОКО - 1 пробирка, 1000 мкл. 5. ВКО - 1 пробирка, 950 мкл. 6. КО-1 - 2 пробирки, по 1500 мкл. 7. КО-2 - 2 пробирки, по 1500 мкл. 8. Инструкция по применению - 1 шт. 9. Паспорт качества - 1 шт. на партию.
- Device Type (English)
- N/A
- Device Type (Russian)
- 285280
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 75754.0
- Registration Number
- РЗН 2022/18686
- 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 qualitative and quantitative determination of hepatitis D virus RNA in human blood plasma samples by real-time polymerase chain reaction with reverse transcription hybridization-fluorescence detection (RT-PCR-RV) "HEP-test-Q" according to TU 21.20.23-020-97638376-2020 , consisting of: 1. RT-PCR buffer - 1 tube, 480 μL. 2. Oligonucleotide mixture - 1 test tube, 1440 μl. 3. PCO - 1 tube, 50 μl. 4. OKO - 1 test tube, 1000 μl. 5. VKO - 1 test tube, 950 μl. 6. KO-1 - 2 test tubes, 1500 μl each. 7. KO-2 - 2 test tubes, 1500 μl each. 8. Instructions for use - 1 pc. 9. 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 2022/18686 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.