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Reagent kit "Cardiolipin antigen for microprecipitation reaction (RMP) solution for diagnostic purposes" according to TU 21.20.23-160-20401675-2022 Composed of: - cardiolipin antigen for RMP - 5 ampoules of 2 ml each; - Choline chloride solution 70% - 1 vial, 5 ml. - Roszdravnadzor Registration ФСР 2012/13044

Access comprehensive regulatory information for Reagent kit "Cardiolipin antigen for microprecipitation reaction (RMP) solution for diagnostic purposes" according to TU 21.20.23-160-20401675-2022 Composed of: - cardiolipin antigen for RMP - 5 ampoules of 2 ml each; - Choline chloride solution 70% - 1 vial, 5 ml. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number ФСР 2012/13044 and manufactured by JSC "NPO "Microgen". The device was registered on January 19, 2023.

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 2b
ФСР 2012/13044
Reagent kit "Cardiolipin antigen for microprecipitation reaction (RMP) solution for diagnostic purposes" according to TU 21.20.23-160-20401675-2022 Composed of: - cardiolipin antigen for RMP - 5 ampoules of 2 ml each; - Choline chloride solution 70% - 1 vial, 5 ml.
Набор реагентов «Антиген кардиолипиновый для реакции микропреципитации (РМП) раствор для диагностических целей» по ТУ 21.20.23-160-20401675-2022 в составе: - антиген кардиолипиновый для РМП - 5 ампул по 2 мл; - раствор холин-хлорида 70 % - 1 флакон, 5 мл.
Roszdravnadzor Registration Number: ФСР 2012/13044
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Device Information
Device Name (English)
Reagent kit "Cardiolipin antigen for microprecipitation reaction (RMP) solution for diagnostic purposes" according to TU 21.20.23-160-20401675-2022 Composed of: - cardiolipin antigen for RMP - 5 ampoules of 2 ml each; - Choline chloride solution 70% - 1 vial, 5 ml.
Device Name (Russian)
Набор реагентов «Антиген кардиолипиновый для реакции микропреципитации (РМП) раствор для диагностических целей» по ТУ 21.20.23-160-20401675-2022 в составе: - антиген кардиолипиновый для РМП - 5 ампул по 2 мл; - раствор холин-хлорида 70 % - 1 флакон, 5 мл.
Device Type (English)
N/A
Device Type (Russian)
244360
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
68587.0
Registration Number
ФСР 2012/13044
Registration Date
January 19, 2023
Manufacturer Information
Manufacturer Name (English)
JSC "NPO "Microgen"
Manufacturer Name (Russian)
АО "НПО "Микроген"
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
Branch of JSC "NPO "Microgen" in Perm "Perm NPO "Biomed", Russia, 614089, Perm, Bratskaya str., 177
Legal Address (Russian)
Филиал АО "НПО "Микроген" в г. Пермь "Пермское НПО "Биомед", Россия, 614089, г. Пермь, ул. Братская, д. 177
Manufacturing Address
127473, Россия, Москва, 2-й Волконский пер., д. 10