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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 - Roszdravnadzor Registration ФСР 2008/03239

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.

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Class 2a
ФСР 2008/03239
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
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
Roszdravnadzor Registration Number: ФСР 2008/03239
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Device Information
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
Registration Information
Registry Key
64681.0
Registration Number
ФСР 2008/03239
Registration Date
June 20, 2022
Manufacturer Information
Manufacturer Name (English)
LLC "MED-EXPRESS-DIAGNOSTICS"
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