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Reagent kit immunochromatographic test system for express detection and identification of the plague pathogen "IH test system Y.pestis" according to TU 9398-091-78095326-2008 - Roszdravnadzor Registration ФСР 2009/05487

Access comprehensive regulatory information for Reagent kit immunochromatographic test system for express detection and identification of the plague pathogen "IH test system Y.pestis" according to TU 9398-091-78095326-2008 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 2009/05487 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 November 26, 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.

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Class 2b
ФСР 2009/05487
Reagent kit immunochromatographic test system for express detection and identification of the plague pathogen "IH test system Y.pestis" according to TU 9398-091-78095326-2008
Набор реагентов иммунохроматографическая тест-система для экспресс-выявления и идентификации возбудителя чумы "ИХ тест-система Y.pestis" по ТУ 9398-091-78095326-2008
Roszdravnadzor Registration Number: ФСР 2009/05487
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Device Information
Device Name (English)
Reagent kit immunochromatographic test system for express detection and identification of the plague pathogen "IH test system Y.pestis" according to TU 9398-091-78095326-2008
Device Name (Russian)
Набор реагентов иммунохроматографическая тест-система для экспресс-выявления и идентификации возбудителя чумы "ИХ тест-система Y.pestis" по ТУ 9398-091-78095326-2008
Device Type (English)
N/A
Device Type (Russian)
188530
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
58320.0
Registration Number
ФСР 2009/05487
Registration Date
November 26, 2021
Manufacturer Information
Legal Address (English)
FBI SSC PMB, Russia, 142279, Moscow region, Serpukhov, Obolensk, ter. "Kvartal A", 10
Legal Address (Russian)
ФБУН ГНЦ ПМБ, 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