Reagent kit for immunochromatographic detection of antibodies to Helicobacter pylori (HP) in serum (plasma) and whole blood (ImmunoChrom-AntiHP-Express) as per TU 9398-001-83129375-2008
Russia·334610·LLC "MED-EXPRESS-DIAGNOSTICS"·Registered June 20, 2022·Class 2a- Device Name (English)
- Reagent kit for immunochromatographic detection of antibodies to Helicobacter pylori (HP) in serum (plasma) and whole blood (ImmunoChrom-AntiHP-Express) as per TU 9398-001-83129375-2008
- Device Name (Russian)
- Набор реагентов для иммунохроматографического выявления антител к Helicobacter pylori (НР) в сыворотке (плазме) и цельной крови (ИммуноХром-антиНР-Экспресс) по ТУ 9398-001-83129375-2008
- Device Type (English)
- N/A
- Device Type (Russian)
- 334610
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 64681.0
- Registration Number
- ФСР 2008/03239
- Registration Date
- June 20, 2022
- Manufacturer Name (English)
- LLC "MED-EXPRESS-DIAGNOSTICS"
- Manufacturer Name (Russian)
- ООО "МЕД-ЭКСПРЕСС-ДИАГНОСТИКА"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- LLC "MED-EXPRESS-DIAGNOSTICS", Russia, 109651, Moscow, Pererva str., 11, bldg. 20, room. 20P, 22P, 24P
- Legal Address (Russian)
- ООО "МЕД-ЭКСПРЕСС-ДИАГНОСТИКА", Россия, 109651, Москва, ул. Перерва, д. 11, стр. 20, помещ. 20П, 22П, 24П
- Manufacturing Address
- 143306, Россия, Московская область, г. Наро-Фоминск, ул. Карла Маркса, д. 1, каб. 52
Access comprehensive regulatory information for Reagent kit for immunochromatographic detection of antibodies to Helicobacter pylori (HP) in serum (plasma) and whole blood (ImmunoChrom-AntiHP-Express) as per TU 9398-001-83129375-2008 in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number ФСР 2008/03239 and manufactured by LLC "MED-EXPRESS-DIAGNOSTICS". The device was registered on June 20, 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.