Russia Roszdravnadzor registration ФСР 2012/13112

Provacek Diagnosticum rickettsial reagent kit for RSK according to TU 21.10.60-157-20401675-2022 Composed of: - Provacek's diagnosticum rickettsial for RSK - 10 ampoules, lyophilizate of 0.5 ml; - Diagnostic serum for Provacek rickettsia dry for RSC - 3 ampoules, lyophilizate from 0.1 ml; Accessories: - ampoule scarifier - 1 pc.

RU: Набор реагентов Диагностикум риккетсиозный Провачека для РСК по ТУ 21.10.60-157-20401675-2022 в составе: - диагностикум риккетсиозный Провачека для РСК - 10 ампул, лиофилизат из 0,5 мл; - сыворотка диагностическая к риккетсиям Провачека сухая для РCК - 3 ампулы, лиофилизат из 0,1 мл; Принадлежности: - скарификатор ампульный - 1 шт.
Russia flagRussia·199950·JSC "NPO "Microgen"·Registered January 18, 2023·Class 2b
Device information
Device Name (English)
Provacek Diagnosticum rickettsial reagent kit for RSK according to TU 21.10.60-157-20401675-2022 Composed of: - Provacek's diagnosticum rickettsial for RSK - 10 ampoules, lyophilizate of 0.5 ml; - Diagnostic serum for Provacek rickettsia dry for RSC - 3 ampoules, lyophilizate from 0.1 ml; Accessories: - ampoule scarifier - 1 pc.
Device Name (Russian)
Набор реагентов Диагностикум риккетсиозный Провачека для РСК по ТУ 21.10.60-157-20401675-2022 в составе: - диагностикум риккетсиозный Провачека для РСК - 10 ампул, лиофилизат из 0,5 мл; - сыворотка диагностическая к риккетсиям Провачека сухая для РCК - 3 ампулы, лиофилизат из 0,1 мл; Принадлежности: - скарификатор ампульный - 1 шт.
Device Type (English)
N/A
Device Type (Russian)
199950
Risk Class
Class 2b
OKPD Code
21.10.60.196
Registration information
Registry Key
68584.0
Registration Number
ФСР 2012/13112
Registration Date
January 18, 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
About this record

Access comprehensive regulatory information for Provacek Diagnosticum rickettsial reagent kit for RSK according to TU 21.10.60-157-20401675-2022 Composed of: - Provacek's diagnosticum rickettsial for RSK - 10 ampoules, lyophilizate of 0.5 ml; - Diagnostic serum for Provacek rickettsia dry for RSC - 3 ampoules, lyophilizate from 0.1 ml; Accessories: - ampoule scarifier - 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 ФСР 2012/13112 and manufactured by JSC "NPO "Microgen". The device was registered on January 18, 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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