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.
Russia·192490·Alkor Bio Company LLC·Registered July 12, 2024·Class 2a- 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
- Registry Key
- 79315.0
- Registration Number
- РЗН 2024/23130
- Registration Date
- July 12, 2024
- Manufacturer Name (English)
- Alkor Bio Company LLC
- Manufacturer Name (Russian)
- ООО "Компания Алкор Био"
- 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
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.