Pure Global

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. - Roszdravnadzor Registration РЗН 2024/22109

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.

Free Database
Powered by Pure Global AI
Roszdravnadzor Official Data
Class 2b
РЗН 2024/22109
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.
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.
Roszdravnadzor Registration Number: РЗН 2024/22109
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Information
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
Registration Information
Registry Key
76921.0
Registration Number
РЗН 2024/22109
Registration Date
March 04, 2024
Manufacturer Information
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