Reagent kit Rapid test for the detection of SARS-CoV-2 antigen by membrane immunochromatographic analysis (COVID-19 Ag rapid test) according to TU 21.20.23-355-78095326-2021, series 02 Composed of: 1. Individually wrapped test cassette - 20 pcs. 2. Extraction solution - 8.0 ml, dropper bottle - 1 pc. 3. Extraction tube and dropper cap - 1 bag of 20 pcs. 4. Instructions for use - 1 pc.
Russia·142010·State Research Center for Applied Microbiology and Biotechnology of the Federal Service for Surveillance on Consumer Rights Protection and Human Welfare·Registered January 28, 2022·N/A- Device Name (English)
- Reagent kit Rapid test for the detection of SARS-CoV-2 antigen by membrane immunochromatographic analysis (COVID-19 Ag rapid test) according to TU 21.20.23-355-78095326-2021, series 02 Composed of: 1. Individually wrapped test cassette - 20 pcs. 2. Extraction solution - 8.0 ml, dropper bottle - 1 pc. 3. Extraction tube and dropper cap - 1 bag of 20 pcs. 4. Instructions for use - 1 pc.
- Device Name (Russian)
- Набор реагентов Экспресс-тест для выявления антигена SARS-CoV-2 методом мембранно-иммунохроматографического анализа (Экспресс-тест COVID-19 Ag) по ТУ 21.20.23-355-78095326-2021, серия 02 в составе: 1. Тест-кассета в индивидуальной упаковке - 20 шт. 2. Раствор для экстракции - 8,0 мл, флакон-капельница - 1 шт. 3. пробирка для экстракции и колпачок-капельница - 1 пакет по 20 шт. 4. Инструкция по применению - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 142010
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 61422.0
- Registration Number
- РЗН 2022/16491
- Registration Date
- January 28, 2022
- Validity Period
- January 01, 2025
- Manufacturer Name (English)
- State Research Center for Applied Microbiology and Biotechnology of the Federal Service for Surveillance on Consumer Rights Protection and Human Welfare
- Manufacturer Name (Russian)
- БУ "Государственный научный центр прикладной микробиологии и биотехнологии" Федеральной службы по надзору в сфере защиты прав потребителей и благополучия человека
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- Federal Budgetary Institution of Science "State Scientific Center for Applied Microbiology and Biotechnology" of the Federal Service for Surveillance on Consumer Rights Protection and Human Wellbeing, Russia, 142279, Moscow Region, Serpukhov, Obolensk, ter. "Kvartal A", 10
- Legal Address (Russian)
- Федеральное бюджетное учреждение науки "Государственный научный центр прикладной микробиологии и биотехнологии" Федеральной службы по надзору в сфере защиты прав потребителей и благополучия человека, Россия, 142279, Московская область, г.о. Серпухов, п. Оболенск, тер. "Квартал А", д. 10
- Manufacturing Address
- 142279, Россия, Московская область, городской округ Серпухов, п. Оболенск, территория "Квартал А", д. 24
Access comprehensive regulatory information for Reagent kit Rapid test for the detection of SARS-CoV-2 antigen by membrane immunochromatographic analysis (COVID-19 Ag rapid test) according to TU 21.20.23-355-78095326-2021, series 02 Composed of: 1. Individually wrapped test cassette - 20 pcs. 2. Extraction solution - 8.0 ml, dropper bottle - 1 pc. 3. Extraction tube and dropper cap - 1 bag of 20 pcs. 4. Instructions for use - 1 pc. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2022/16491 and manufactured by State Research Center for Applied Microbiology and Biotechnology of the Federal Service for Surveillance on Consumer Rights Protection and Human Welfare. The device was registered on January 28, 2022.
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.