Reagent kit for qualitative and quantitative DNA determination of human herpes viruses type 4, 5 and 6 (EBV, CMV, HHV6) by polymerase chain reaction with real-time detection "Herpes test" according to TU 21.20.23-055-97638376-2022 , consisting of: 1. PCR buffer: 1 tube, 480 μL. 2. Primer mix: 1 tube, 480 μL. 3. PKO-1: 1 tube, 480 μl. 4. PKO-2: 1 tube, 480 μl. 5. OKO: 2 test tubes, 1600 μl each. The Herpes Test reagent kit includes: - Herpes test reagent kit - 1 pc.; - Instructions for use - 1 pc.; - Quality passport - 1 pc. per batch.
Russia·327670·LLC "TestGen"·Registered March 04, 2024·Class 2b- Device Name (English)
- Reagent kit for qualitative and quantitative DNA determination of human herpes viruses type 4, 5 and 6 (EBV, CMV, HHV6) by polymerase chain reaction with real-time detection "Herpes test" according to TU 21.20.23-055-97638376-2022 , consisting of: 1. PCR buffer: 1 tube, 480 μL. 2. Primer mix: 1 tube, 480 μL. 3. PKO-1: 1 tube, 480 μl. 4. PKO-2: 1 tube, 480 μl. 5. OKO: 2 test tubes, 1600 μl each. The Herpes Test reagent kit includes: - Herpes test reagent kit - 1 pc.; - Instructions for use - 1 pc.; - Quality passport - 1 pc. per batch.
- Device Name (Russian)
- Набор реагентов для качественного и количественного определения ДНК вирусов герпеса человека 4, 5 и 6 типа (EBV, CMV, HHV6) методом полимеразной цепной реакции с детекцией в режиме реального времени "Герпес-тест" по ТУ 21.20.23-055-97638376-2022 , в составе: 1. ПЦР-буфер: 1 пробирка, 480 мкл. 2. Праймер-микс: 1 пробирка, 480 мкл. 3. ПКО-1: 1 пробирка, 480 мкл. 4. ПКО-2: 1 пробирка, 480 мкл. 5. ОКО: 2 пробирки, по 1600 мкл. В комплект поставки набора реагентов «Герпес-тест» входит: - Набор реагентов «Герпес-тест» - 1 шт.; - Инструкция по применению - 1 шт.; - Паспорт качества - 1 шт. на партию.
- Device Type (English)
- N/A
- Device Type (Russian)
- 327670
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 76921.0
- Registration Number
- РЗН 2024/22109
- Registration Date
- March 04, 2024
- Manufacturer Name (English)
- LLC "TestGen"
- Manufacturer Name (Russian)
- ООО "ТестГен"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- LLC "TestGen", Russia, 432072, Ulyanovsk, 44th Inzhenerny proezd, 9, pomeshch. 35, 36, 37
- Legal Address (Russian)
- ООО "ТестГен", Россия, 432072, г. Ульяновск, 44-й Инженерный пр-д, д. 9, помещ. 35, 36, 37
- 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 DNA determination of human herpes viruses type 4, 5 and 6 (EBV, CMV, HHV6) by polymerase chain reaction with real-time detection "Herpes test" according to TU 21.20.23-055-97638376-2022 , consisting of: 1. PCR buffer: 1 tube, 480 μL. 2. Primer mix: 1 tube, 480 μL. 3. PKO-1: 1 tube, 480 μl. 4. PKO-2: 1 tube, 480 μl. 5. OKO: 2 test tubes, 1600 μl each. The Herpes Test reagent kit includes: - Herpes test reagent kit - 1 pc.; - Instructions for use - 1 pc.; - Quality passport - 1 pc. per batch. 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 2024/22109 and manufactured by LLC "TestGen". The device was registered on March 04, 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.