Reagent kit for qualitative detection of coronavirus RNA (SARS-CoV-2) by direct RT-PCR-RV "Cito-CoV-2-Test-L" according to TU 21.20.23-062-97638376-2022 Composed of: 1. LRS-Cito: 96 tubes connected by "bridges" into a plate packed in a rack with a lid (lyophilizate). 2. LRS-Cito recovery solution: 1 tube, 1800 μl. 3. PCO: 1 vial (lyophilizate). 4. Solution for the recovery of PKO: 1 tube, 200 μl. 5. OKO: 1 tube, 480 μl. 6. Instructions for use - 1 pc. 7. Quality passport - 1 pc. per batch.
Russia·142160·LLC "TestGen"·Registered September 23, 2024·N/A- Device Name (English)
- Reagent kit for qualitative detection of coronavirus RNA (SARS-CoV-2) by direct RT-PCR-RV "Cito-CoV-2-Test-L" according to TU 21.20.23-062-97638376-2022 Composed of: 1. LRS-Cito: 96 tubes connected by "bridges" into a plate packed in a rack with a lid (lyophilizate). 2. LRS-Cito recovery solution: 1 tube, 1800 μl. 3. PCO: 1 vial (lyophilizate). 4. Solution for the recovery of PKO: 1 tube, 200 μl. 5. OKO: 1 tube, 480 μl. 6. Instructions for use - 1 pc. 7. Quality passport - 1 pc. per batch.
- Device Name (Russian)
- Набор реагентов для качественного выявления РНК коронавируса (SARS-CoV-2) методом прямой ОТ-ПЦР-РВ «Cito-CoV-2-Test-L» по ТУ 21.20.23-062-97638376-2022 в составе: 1. ЛРС-Cito: 96 пробирок, объединенных «мостиками» в планшет, упакованный в штатив с крышкой (лиофилизат). 2. Раствор для восстановления ЛРС-Cito: 1 пробирка, 1800 мкл. 3. ПКО: 1 флакон (лиофилизат). 4. Раствор для восстановления ПКО: 1 пробирка, 200 мкл. 5. ОКО: 1 пробирка, 480 мкл. 6. Инструкция по применению - 1 шт. 7. Паспорт качества - 1 шт. на партию.
- Device Type (English)
- N/A
- Device Type (Russian)
- 142160
- Risk Class
- N/A
- OKPD Code
- 20.59.52.195
- Registry Key
- 80446
- Registration Number
- РЗН 2024/23676
- Registration Date
- September 23, 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 region, Ulyanovsk, 44th Inzhenerny proezd, 9, pomeshch. 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53
- Legal Address (Russian)
- ООО "ТестГен", Россия, 432072, Ульяновская область, г. Ульяновск, 44-й Инженерный пр-д, д. 9, помещ. 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53
- Manufacturing Address
- 432072, Россия, г. Ульяновск, 44-й Инженерный пр-д, д. 9, офис 13
Access comprehensive regulatory information for Reagent kit for qualitative detection of coronavirus RNA (SARS-CoV-2) by direct RT-PCR-RV "Cito-CoV-2-Test-L" according to TU 21.20.23-062-97638376-2022 Composed of: 1. LRS-Cito: 96 tubes connected by "bridges" into a plate packed in a rack with a lid (lyophilizate). 2. LRS-Cito recovery solution: 1 tube, 1800 μl. 3. PCO: 1 vial (lyophilizate). 4. Solution for the recovery of PKO: 1 tube, 200 μl. 5. OKO: 1 tube, 480 μl. 6. Instructions for use - 1 pc. 7. 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 2024/23676 and manufactured by LLC "TestGen". The device was registered on September 23, 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.