Reagent kit Rapid test for the detection of SARS-CoV-2 antigen by membrane-immunochromatographic analysis (COVID-19 Ag rapid test) according to TU 21.20.23-340-78095326-2021, series 01 Composed of: 1. Express test in individual packaging, plastic panel - 20 pcs. 2. Universal probe type A3 in individual packaging, sterile, manufactured by Medical Devices LLC, RU No RZN 2018/7058 - 20 pcs. 3. Disposable pipette - 20 pcs. 4. Extraction solution - screw tube, 0.35 ml - 20 pcs. 5. Instructions for use - 1 pc.
Russia·142010·BU SSC PMB·Registered February 02, 2021·Class 2b- 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 21.20.23-340-78095326-2021, series 01 Composed of: 1. Express test in individual packaging, plastic panel - 20 pcs. 2. Universal probe type A3 in individual packaging, sterile, manufactured by Medical Devices LLC, RU No RZN 2018/7058 - 20 pcs. 3. Disposable pipette - 20 pcs. 4. Extraction solution - screw tube, 0.35 ml - 20 pcs. 5. 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 21.20.23-340-78095326-2021, серия 01 в составе: 1. Экспресс-тест в индивидуальной упаковке, пластиковая панель - 20 шт. 2. Зонд тип А3 универсальный в индивидуальной упаковке, стерильный, производства ООО "Медицинские изделия", РУ № РЗН 2018/7058 - 20 шт. 3. Пипетка одноразовая - 20 шт. 4. Раствор для экстракции - винтовая пробирка, по 0,35 мл - 20 шт. 5. Инструкция по применению - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 142010
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 51309.0
- Registration Number
- РЗН 2021/13393
- Registration Date
- February 02, 2021
- Validity Period
- January 01, 2025
- Manufacturer Name (English)
- BU SSC PMB
- Manufacturer Name (Russian)
- БУ ГНЦ ПМБ
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- FBI SSC PMB, Russia, 142279, Moscow region, Obolensk, Serpukhov urban district, ter. "Kvartal A", 10
- Legal Address (Russian)
- ФБУН ГНЦ ПМБ, Россия, 142279, Московская область, р.п. Оболенск, городской округ Серпухов, тер. "Квартал А", д. 10
- Manufacturing Address
- 142279, Россия, Московская область, г. Серпухов, р.п. Оболенск, территория "Квартал А"
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 21.20.23-340-78095326-2021, series 01 Composed of: 1. Express test in individual packaging, plastic panel - 20 pcs. 2. Universal probe type A3 in individual packaging, sterile, manufactured by Medical Devices LLC, RU No RZN 2018/7058 - 20 pcs. 3. Disposable pipette - 20 pcs. 4. Extraction solution - screw tube, 0.35 ml - 20 pcs. 5. Instructions for use - 1 pc. 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 2021/13393 and manufactured by BU SSC PMB. The device was registered on February 02, 2021.
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.