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Reagent based on monoclonal antibodies to surface leukocyte antigens labeled with StatusFlow-2 fluorochromes according to TU 21.20.23-699-98539446-2023 , in the following versions: I. Version No1, consisting of: 1. Tetra (B) - 1 tube (1.2 ml). 2. Instructions for use. 3. Passport. II. Version No2, consisting of: 1. Tetra (BR) - 1 tube (1.2 ml). 2. Instructions for use. 3. Passport. - Roszdravnadzor Registration РЗН 2024/23130

Access comprehensive regulatory information for Reagent based on monoclonal antibodies to surface leukocyte antigens labeled with StatusFlow-2 fluorochromes according to TU 21.20.23-699-98539446-2023 , in the following versions: I. Version No1, consisting of: 1. Tetra (B) - 1 tube (1.2 ml). 2. Instructions for use. 3. Passport. II. Version No2, consisting of: 1. Tetra (BR) - 1 tube (1.2 ml). 2. Instructions for use. 3. Passport. in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number РЗН 2024/23130 and manufactured by Alkor Bio Company LLC. The device was registered on July 12, 2024.

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
РЗН 2024/23130
Reagent based on monoclonal antibodies to surface leukocyte antigens labeled with StatusFlow-2 fluorochromes according to TU 21.20.23-699-98539446-2023 , in the following versions: I. Version No1, consisting of: 1. Tetra (B) - 1 tube (1.2 ml). 2. Instructions for use. 3. Passport. II. Version No2, consisting of: 1. Tetra (BR) - 1 tube (1.2 ml). 2. Instructions for use. 3. Passport.
Реагент на основе моноклональных антител к поверхностным лейкоцитарным антигенам, меченых флуорохромами "СтатусФлоу-2" по ТУ 21.20.23-699-98539446-2023 , в вариантах исполнения: I. Вариант исполнения №1, в составе: 1. Тетра (В) - 1 пробирка (1,2 мл). 2. Инструкция по применению. 3. Паспорт. II. Вариант исполнения №2, в составе: 1. Тетра (BR) - 1 пробирка (1,2 мл). 2. Инструкция по применению. 3. Паспорт.
Roszdravnadzor Registration Number: РЗН 2024/23130
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Device Information
Device Name (English)
Reagent based on monoclonal antibodies to surface leukocyte antigens labeled with StatusFlow-2 fluorochromes according to TU 21.20.23-699-98539446-2023 , in the following versions: I. Version No1, consisting of: 1. Tetra (B) - 1 tube (1.2 ml). 2. Instructions for use. 3. Passport. II. Version No2, consisting of: 1. Tetra (BR) - 1 tube (1.2 ml). 2. Instructions for use. 3. Passport.
Device Name (Russian)
Реагент на основе моноклональных антител к поверхностным лейкоцитарным антигенам, меченых флуорохромами "СтатусФлоу-2" по ТУ 21.20.23-699-98539446-2023 , в вариантах исполнения: I. Вариант исполнения №1, в составе: 1. Тетра (В) - 1 пробирка (1,2 мл). 2. Инструкция по применению. 3. Паспорт. II. Вариант исполнения №2, в составе: 1. Тетра (BR) - 1 пробирка (1,2 мл). 2. Инструкция по применению. 3. Паспорт.
Device Type (English)
N/A
Device Type (Russian)
192490
Risk Class
Class 2a
OKPD Code
21.20.23.110
Registration Information
Registry Key
79315.0
Registration Number
РЗН 2024/23130
Registration Date
July 12, 2024
Manufacturer Information
Manufacturer Name (English)
Alkor Bio Company LLC
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
Alkor Bio Company, LLC, St. Petersburg, 192148, Zheleznodorozhny, pr-kt, 40, lit. And.
Legal Address (Russian)
ООО "Компания Алкор Био", Россия, 192148, Санкт-Петербург, Железнодорожный пр-кт, д. 40, лит. А.
Manufacturing Address
192148, Россия, Санкт-Петербург, Железнодорожный пр-кт, д. 40, лит. А, офис 217