AllergoFlow reagent kit for semi-quantitative cytofluorimetric determination of the level of basophil activation in human whole peripheral blood, according to TU 21.20.23-723-98539446-2023 Options: I. Starter Configuration No1 1. AllergoFlow reagent kit - 1 pc., consisting of: - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - FMO-control-647T - 1 pr. (10 μl); - Cocktail of antibodies 647T - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution - 1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. II. Starter Configuration No2 1. AllergoFlow reagent kit - 1 pc., contained; - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - FMO-control-ARS - 1 pc (10 μl); - Cocktail of antibodies APC - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution -1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. III. Basic Configuration No1 1. AllergoFlow reagent kit - 1 pc., consisting of: - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - Cocktail of antibodies 647T - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution - 1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. IV. Basic Configuration No2 1. AllergoFlow reagent kit - 1 pc., consisting of: - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - Cocktail of antibodies APC - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution - 1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc.
Russia·197230·Alkor Bio Company LLC·Registered June 07, 2024·Class 2a- Device Name (English)
- AllergoFlow reagent kit for semi-quantitative cytofluorimetric determination of the level of basophil activation in human whole peripheral blood, according to TU 21.20.23-723-98539446-2023 Options: I. Starter Configuration No1 1. AllergoFlow reagent kit - 1 pc., consisting of: - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - FMO-control-647T - 1 pr. (10 μl); - Cocktail of antibodies 647T - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution - 1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. II. Starter Configuration No2 1. AllergoFlow reagent kit - 1 pc., contained; - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - FMO-control-ARS - 1 pc (10 μl); - Cocktail of antibodies APC - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution -1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. III. Basic Configuration No1 1. AllergoFlow reagent kit - 1 pc., consisting of: - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - Cocktail of antibodies 647T - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution - 1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. IV. Basic Configuration No2 1. AllergoFlow reagent kit - 1 pc., consisting of: - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - Cocktail of antibodies APC - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution - 1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc.
- Device Name (Russian)
- Набор реагентов для полуколичественного цитофлуориметрического определения уровня активации базофилов в цельной периферической крови человека "АллергоФлоу", по ТУ 21.20.23-723-98539446-2023 , варианты исполнения: I. Стартовая комплектация №1 1. Набор реагентов «АллергоФлоу» - 1 шт., в составе: - Буфер для инкубации - 1 фл. (7 мл); - Положительный контроль - 1 фл.; - ФМО-контроль-647Т - 1 пр. (10 мкл); - Коктейль антител 647Т - 1 пр. (360 мкл); - Стоп-раствор - 1 фл. (7 мл); - Лизирующий раствор (10Х) - 1 фл. (12 мл); - Фиксирующий раствор - 1 фл. (50 мл); - Инструкция по применению - 1 шт.; - Паспорт - 1 шт. II. Стартовая комплектация №2 1. Набор реагентов «АллергоФлоу» - 1 шт., в составе; - Буфер для инкубации - 1 фл. (7 мл); - Положительный контроль - 1 фл.; - ФМО-контроль-АРС - 1 пр. (10 мкл); - Коктейль антител АРС - 1 пр. (360 мкл); - Стоп-раствор - 1 фл. (7 мл); - Лизирующий раствор (10Х) - 1 фл. (12 мл); - Фиксирующий раствор -1 фл. (50 мл); - Инструкция по применению - 1 шт.; - Паспорт - 1 шт. III. Базовая комплектация №1 1. Набор реагентов «АллергоФлоу» - 1 шт., в составе: - Буфер для инкубации - 1 фл. (7 мл); - Положительный контроль - 1 фл.; - Коктейль антител 647Т - 1 пр. (360 мкл); - Стоп-раствор - 1 фл. (7 мл); - Лизирующий раствор (10Х) - 1 фл. (12 мл); - Фиксирующий раствор - 1 фл. (50 мл); - Инструкция по применению - 1 шт.; - Паспорт - 1 шт. IV. Базовая комплектация №2 1. Набор реагентов «АллергоФлоу» - 1 шт., в составе: - Буфер для инкубации - 1 фл. (7 мл); - Положительный контроль - 1 фл.; - Коктейль антител АРС - 1 пр. (360 мкл); - Стоп-раствор - 1 фл. (7 мл); - Лизирующий раствор (10Х) - 1 фл. (12 мл); - Фиксирующий раствор - 1 фл. (50 мл); - Инструкция по применению - 1 шт.; - Паспорт - 1 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 197230
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78809.0
- Registration Number
- РЗН 2024/22878
- Registration Date
- June 07, 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, Russia, Zheleznodorozhny prospekt, 40, letter A
- Legal Address (Russian)
- ООО "Компания Алкор Био", Россия, 192148, Санкт-Петербург, Железнодорожный пр-кт, д. 40, литера А
- Manufacturing Address
- 192148, Россия, Санкт-Петербург, Железнодорожный пр-кт, д. 40, литера А, офис 217
Access comprehensive regulatory information for AllergoFlow reagent kit for semi-quantitative cytofluorimetric determination of the level of basophil activation in human whole peripheral blood, according to TU 21.20.23-723-98539446-2023 Options: I. Starter Configuration No1 1. AllergoFlow reagent kit - 1 pc., consisting of: - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - FMO-control-647T - 1 pr. (10 μl); - Cocktail of antibodies 647T - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution - 1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. II. Starter Configuration No2 1. AllergoFlow reagent kit - 1 pc., contained; - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - FMO-control-ARS - 1 pc (10 μl); - Cocktail of antibodies APC - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution -1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. III. Basic Configuration No1 1. AllergoFlow reagent kit - 1 pc., consisting of: - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - Cocktail of antibodies 647T - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution - 1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. IV. Basic Configuration No2 1. AllergoFlow reagent kit - 1 pc., consisting of: - Incubation buffer - 1 fl. (7 ml); - Positive control - 1 fl.; - Cocktail of antibodies APC - 1 pr. (360 μl); - Stop solution - 1 bottle. (7 ml); - Lysis solution (10X) - 1 bottle. (12 ml); - Fixing solution - 1 fl. (50 ml); - Instructions for use - 1 pc.; - Passport - 1 pc. 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 2024/22878 and manufactured by Alkor Bio Company LLC. The device was registered on June 07, 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.