Reagent kit for the detection of hepatitis B virus (HBV) DNA by polymerase chain reaction (PCR) (VGB-GENE) according to TU 9398-419-46482062-2016 1. PROBA-NK set of reagents for nucleic acid isolation, including: - Lysis solution - 1 vial; - Precipitation reagent - 1 vial; - Rinsing solution No 1 - 1 vial; - Rinsing solution No 2 - 1 vial; - Dissolution buffer - 4 tubes; - Negative control sample - 2 tubes; - Internal control sample (DNA-BK) - 1 tube; - Internal control sample (RNA-BK) -1 tube. 2. Set of reagents for PCR amplification (type 286800), in the following formats: - with real-time detection; - with fluorescence endpoint detection; - with detection by gel electrophoresis, The reagent kit includes: - Amplification mixture sealed with paraffin - no more than 100 tubes or 12 strips of 8 tubes; - PCR buffer - 2 tubes; - TechnoTak polymerase - 1 tube; - Mineral oil - 2 test tubes; - Positive control sample - 1 tube. Accessories: - Strip lids - 12 pcs. (included in the reagent kit when packing in strips). 3. A set of reagents for DNA detection by gel electrophoresis, including: - Mixture for electrophoresis - 1 packet; - Agarose gel - 5 plates.
Russia·286800·DNA-Technology TS LLC·Registered August 07, 2024·N/A- Device Name (English)
- Reagent kit for the detection of hepatitis B virus (HBV) DNA by polymerase chain reaction (PCR) (VGB-GENE) according to TU 9398-419-46482062-2016 1. PROBA-NK set of reagents for nucleic acid isolation, including: - Lysis solution - 1 vial; - Precipitation reagent - 1 vial; - Rinsing solution No 1 - 1 vial; - Rinsing solution No 2 - 1 vial; - Dissolution buffer - 4 tubes; - Negative control sample - 2 tubes; - Internal control sample (DNA-BK) - 1 tube; - Internal control sample (RNA-BK) -1 tube. 2. Set of reagents for PCR amplification (type 286800), in the following formats: - with real-time detection; - with fluorescence endpoint detection; - with detection by gel electrophoresis, The reagent kit includes: - Amplification mixture sealed with paraffin - no more than 100 tubes or 12 strips of 8 tubes; - PCR buffer - 2 tubes; - TechnoTak polymerase - 1 tube; - Mineral oil - 2 test tubes; - Positive control sample - 1 tube. Accessories: - Strip lids - 12 pcs. (included in the reagent kit when packing in strips). 3. A set of reagents for DNA detection by gel electrophoresis, including: - Mixture for electrophoresis - 1 packet; - Agarose gel - 5 plates.
- Device Name (Russian)
- Набор реагентов для выявления ДНК вируса гепатита В (HBV) методом полимеразной цепной реакции (ПЦР) (ВГБ-ГЕН) по ТУ 9398-419-46482062-2016 1. Комплект реагентов для выделения нуклеиновых кислот ПРОБА-НК, включающий: - Лизирующий раствор - 1 флакон; - Реагент для преципитации - 1 флакон; - Промывочный раствор № 1 - 1 флакон; - Промывочный раствор № 2 - 1 флакон; - Буфер для растворения - 4 пробирки; - Отрицательный контрольный образец - 2 пробирки; - Внутренний контрольный образец (ДНК-ВК) -1 пробирка; - Внутренний контрольный образец (РНК-ВК) -1 пробирка. 2. Комплект реагентов для ПЦР-амплификации (вид 286800), в форматах: - с детекцией в режиме реального времени; - с флуоресцентной детекцией по конечной точке; - с детекцией методом гель-электрофореза, Комплект реагентов включает: - Смесь для амплификации, запечатанная парафином - не более 100 пробирок или 12 стрипов по 8 пробирок; - ПЦР-буфер - 2 пробирки; - Полимераза ТехноТаq - 1 пробирка; - Минеральное масло - 2 пробирки; - Положительный контрольный образец - 1 пробирка. Принадлежности: - Крышки для стрипов - 12 шт. (входят в состав набора реагентов при расфасовке в стрипы). 3. Комплект реагентов для детекции ДНК методом гель-электрофореза, включающий: - Смесь для электрофореза - 1 пакет; - Агарозный гель - 5 пластин.
- Device Type (English)
- N/A
- Device Type (Russian)
- 286800
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 80336.0
- Registration Number
- ФСР 2008/03507
- Registration Date
- August 07, 2024
- Manufacturer Name (English)
- DNA-Technology TS LLC
- Manufacturer Name (Russian)
- ООО "ДНК-Технология ТС"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. DNA-Technology TS LLC, 20, bldg. 4, Moscow, 117246, Russia. 2. NPO DNA-Technology LLC, 3 Zheleznodorozhnaya Street, Protvino, Moscow Region, 142281.
- Legal Address (Russian)
- 1. ООО "ДНК-Технология ТС", Россия, 117246, Москва, Научный пр-д, д. 20, стр. 4. 2. ООО "НПО ДНК-Технология", Россия, 142281, Московская область, г. Протвино, ул. Железнодорожная, д. 3.
- Manufacturing Address
- 117246, Россия, Москва, Научный пр-д, д. 20, стр. 4
Access comprehensive regulatory information for Reagent kit for the detection of hepatitis B virus (HBV) DNA by polymerase chain reaction (PCR) (VGB-GENE) according to TU 9398-419-46482062-2016 1. PROBA-NK set of reagents for nucleic acid isolation, including: - Lysis solution - 1 vial; - Precipitation reagent - 1 vial; - Rinsing solution No 1 - 1 vial; - Rinsing solution No 2 - 1 vial; - Dissolution buffer - 4 tubes; - Negative control sample - 2 tubes; - Internal control sample (DNA-BK) - 1 tube; - Internal control sample (RNA-BK) -1 tube. 2. Set of reagents for PCR amplification (type 286800), in the following formats: - with real-time detection; - with fluorescence endpoint detection; - with detection by gel electrophoresis, The reagent kit includes: - Amplification mixture sealed with paraffin - no more than 100 tubes or 12 strips of 8 tubes; - PCR buffer - 2 tubes; - TechnoTak polymerase - 1 tube; - Mineral oil - 2 test tubes; - Positive control sample - 1 tube. Accessories: - Strip lids - 12 pcs. (included in the reagent kit when packing in strips). 3. A set of reagents for DNA detection by gel electrophoresis, including: - Mixture for electrophoresis - 1 packet; - Agarose gel - 5 plates. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФСР 2008/03507 and manufactured by DNA-Technology TS LLC. The device was registered on August 07, 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.