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Reagent kit for qualitative and quantitative DNA determination of human herpes virus type 5 (CMV) by polymerase chain reaction with real-time detection "CMV-test" according to TU 21.20.23-058-97638376-2022 Composed 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 CMV-test reagent kit includes: - "CMV-test" reagent kit - 1 pc.; - Instructions for use ? 1 pc.; - Quality passport ? 1 pc per batch. - Roszdravnadzor Registration РЗН 2024/22026

Access comprehensive regulatory information for Reagent kit for qualitative and quantitative DNA determination of human herpes virus type 5 (CMV) by polymerase chain reaction with real-time detection "CMV-test" according to TU 21.20.23-058-97638376-2022 Composed 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 CMV-test reagent kit includes: - "CMV-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 2024/22026 and manufactured by LLC "TestGen". The device was registered on February 13, 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.

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Class 2b
РЗН 2024/22026
Reagent kit for qualitative and quantitative DNA determination of human herpes virus type 5 (CMV) by polymerase chain reaction with real-time detection "CMV-test" according to TU 21.20.23-058-97638376-2022 Composed 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 CMV-test reagent kit includes: - "CMV-test" reagent kit - 1 pc.; - Instructions for use ? 1 pc.; - Quality passport ? 1 pc per batch.
Набор реагентов для качественного и количественного определения ДНК вируса герпеса человека 5 типа (CMV) методом полимеразной цепной реакции с детекцией в режиме реального времени "CMV-тест" по ТУ 21.20.23-058-97638376-2022 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 «CMV-тест» входит: - Набор реагентов «CMV-тест» - 1 шт.; - Инструкция по применению ? 1 шт.; - Паспорт качества ? 1 шт. на партию.
Roszdravnadzor Registration Number: РЗН 2024/22026
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Device Information
Device Name (English)
Reagent kit for qualitative and quantitative DNA determination of human herpes virus type 5 (CMV) by polymerase chain reaction with real-time detection "CMV-test" according to TU 21.20.23-058-97638376-2022 Composed 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 CMV-test reagent kit includes: - "CMV-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 вируса герпеса человека 5 типа (CMV) методом полимеразной цепной реакции с детекцией в режиме реального времени "CMV-тест" по ТУ 21.20.23-058-97638376-2022 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 «CMV-тест» входит: - Набор реагентов «CMV-тест» - 1 шт.; - Инструкция по применению ? 1 шт.; - Паспорт качества ? 1 шт. на партию.
Device Type (English)
N/A
Device Type (Russian)
217820
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
76538.0
Registration Number
РЗН 2024/22026
Registration Date
February 13, 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