Reagent kit for the determination of antibodies to O-antigens of Shigella Sonne and Flexner in the passive hemagglutination reaction "Shigella RPGA" according to TU 21.20.23-296-70423725-2021, with accessories Options: I. General set, consisting of: - Test-erythrocytes Flexner 1-5 (TE FL 1-5) - 1 bottle. (5.0 ml); - Test erythrocytes Flexner 6 (TE FL 6) - 1 bottle. (5.0 ml); - Sonne erythrocyte test (TE Sonne) - 1 vial. (5.0 ml); - Control erythrocytes EC - 1 vial. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (30 ml); - Control positive sample K+FL 1-5 - 1 fl. (0.25 ml); - Control positive sample K+FL 6 - 1 fl. (0.25 ml); - Control positive sample K+Zonne - 1 vial. (0.25 ml); - Control negative sample - K- - 1 fl. (0.25 ml); - Microtitration plate - 3 pcs. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. II. Flexner 1-5 set, consisting of: - Test-erythrocytes Flexner 1-5 (TE FL 1-5) - 1 bottle. (5.0 ml); - Control erythrocytes - EC - 1 fl. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (10 ml); - Control positive sample - K+FL 1-5 - 1 fl. (0.25 ml); - Control negative sample - K- - 1 fl. (0.25 ml); - Microtitration plate - 1 pc. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. III. Flexner 6 set, consisting of: - Test erythrocytes Flexner 6 (TE FL 6) - 1 bottle. (5.0 ml); - Control erythrocytes - EC - 1 fl. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (10 ml); - Control positive sample - K+FL 6 -1 fl. (0.25 ml); - Control negative sample - K- - 1 fl. (0.25 ml); - Microtitration plate - 1 pc. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. IV. Sonne's set, consisting of: - Sonne erythrocyte test (TE Sonne) - 1 vial. (5.0 ml); - Control erythrocytes - EC - 1 fl. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (10 ml); - Control positive sample - K+Zonne - 1 vial. (0.25 ml); - Control negative sample - K- -1 fl. (0.25 ml); - Microtitration plate - 1 pc. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs.
Russia·193000·ECOlab JSC·Registered August 08, 2024·Class 2b- Device Name (English)
- Reagent kit for the determination of antibodies to O-antigens of Shigella Sonne and Flexner in the passive hemagglutination reaction "Shigella RPGA" according to TU 21.20.23-296-70423725-2021, with accessories Options: I. General set, consisting of: - Test-erythrocytes Flexner 1-5 (TE FL 1-5) - 1 bottle. (5.0 ml); - Test erythrocytes Flexner 6 (TE FL 6) - 1 bottle. (5.0 ml); - Sonne erythrocyte test (TE Sonne) - 1 vial. (5.0 ml); - Control erythrocytes EC - 1 vial. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (30 ml); - Control positive sample K+FL 1-5 - 1 fl. (0.25 ml); - Control positive sample K+FL 6 - 1 fl. (0.25 ml); - Control positive sample K+Zonne - 1 vial. (0.25 ml); - Control negative sample - K- - 1 fl. (0.25 ml); - Microtitration plate - 3 pcs. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. II. Flexner 1-5 set, consisting of: - Test-erythrocytes Flexner 1-5 (TE FL 1-5) - 1 bottle. (5.0 ml); - Control erythrocytes - EC - 1 fl. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (10 ml); - Control positive sample - K+FL 1-5 - 1 fl. (0.25 ml); - Control negative sample - K- - 1 fl. (0.25 ml); - Microtitration plate - 1 pc. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. III. Flexner 6 set, consisting of: - Test erythrocytes Flexner 6 (TE FL 6) - 1 bottle. (5.0 ml); - Control erythrocytes - EC - 1 fl. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (10 ml); - Control positive sample - K+FL 6 -1 fl. (0.25 ml); - Control negative sample - K- - 1 fl. (0.25 ml); - Microtitration plate - 1 pc. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. IV. Sonne's set, consisting of: - Sonne erythrocyte test (TE Sonne) - 1 vial. (5.0 ml); - Control erythrocytes - EC - 1 fl. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (10 ml); - Control positive sample - K+Zonne - 1 vial. (0.25 ml); - Control negative sample - K- -1 fl. (0.25 ml); - Microtitration plate - 1 pc. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs.
- Device Name (Russian)
- Набор реагентов для определения антител к О-антигенам шигелл Зонне и Флекснера в реакции пассивной гемагглютинации "Шигелла РПГА" по ТУ 21.20.23-296-70423725-2021, с принадлежностями варианты исполнения: I. Набор общий, в составе: - Тест-эритроциты Флекснер 1-5 (ТЭ ФЛ 1-5) - 1 фл. (5,0 мл); - Тест-эритроциты Флекснер 6 (ТЭ ФЛ 6) - 1 фл. (5,0 мл); - Тест-эритроциты Зонне (ТЭ Зонне) - 1 фл. (5,0 мл); - Контрольные эритроциты КЭ - 1 фл. (5,0 мл); - Раствор для разведения образцов - РРО - 1 фл. (30 мл); - Контрольный положительный образец К+ФЛ 1-5 - 1 фл. (0,25 мл); - Контрольный положительный образец К+ФЛ 6 - 1 фл. (0,25 мл); - Контрольный положительный образец К+Зонне - 1 фл. (0,25 мл); - Контрольный отрицательный образец - К- - 1 фл. (0,25 мл); - Планшет для микротитрования - 3 шт. Принадлежности: - Вспомогательные пластиковые (ПВХ) емкости - 3 шт. II. Набор Флекснер 1-5, в составе: - Тест-эритроциты Флекснер 1-5 (ТЭ ФЛ 1-5) - 1 фл. (5,0 мл); - Контрольные эритроциты - КЭ - 1 фл. (5,0 мл); - Раствор для разведения образцов - РРО - 1 фл. (10 мл); - Контрольный положительный образец - К+ФЛ 1-5 - 1 фл. (0,25 мл); - Контрольный отрицательный образец - К- - 1 фл. (0,25 мл); - Планшет для микротитрования - 1 шт. Принадлежности: - Вспомогательные пластиковые (ПВХ) емкости - 3 шт. III. Набор Флекснер 6, в составе: - Тест-эритроциты Флекснер 6 (ТЭ ФЛ 6) - 1 фл. (5,0 мл); - Контрольные эритроциты - КЭ - 1 фл. (5,0 мл); - Раствор для разведения образцов - РРО - 1 фл. (10 мл); - Контрольный положительный образец - К+ФЛ 6 -1 фл. (0.25 мл); - Контрольный отрицательный образец - К- - 1 фл. (0.25 мл); - Планшет для микротитрования - 1 шт. Принадлежности: - Вспомогательные пластиковые (ПВХ) емкости - 3 шт. IV. Набор Зонне, в составе: - Тест-эритроциты Зонне (ТЭ Зонне) - 1 фл. (5,0 мл); - Контрольные эритроциты - КЭ - 1 фл. (5,0 мл); - Раствор для разведения образцов - РРО - 1 фл. (10 мл); - Контрольный положительный образец - К+Зонне - 1 фл. (0,25 мл); - Контрольный отрицательный образец - К- -1 фл. (0,25 мл); - Планшет для микротитрования - 1 шт. Принадлежности: - Вспомогательные пластиковые (ПВХ) емкости - 3 шт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 193000
- Risk Class
- Class 2b
- OKPD Code
- 21.20.23.110
- Registry Key
- 80643.0
- Registration Number
- РЗН 2022/17953
- Registration Date
- August 08, 2024
- Manufacturer Name (English)
- ECOlab JSC
- Manufacturer Name (Russian)
- АО "ЭКОлаб"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- ECOlab JSC, 1a, Budennogo Street, Elektrogorsk, Pavlovo-Posadsky, Moscow Region, 142530, Russia
- Legal Address (Russian)
- АО "ЭКОлаб", Россия, 142530, Московская область, г.о. Павлово - Посадский, г. Электрогорск, ул. Буденного, д. 1а
- Manufacturing Address
- 142530, Россия, Московская область, г.о. Павлово-Посадский, г. Электрогорск, ул. Буденного, д. 1
Access comprehensive regulatory information for Reagent kit for the determination of antibodies to O-antigens of Shigella Sonne and Flexner in the passive hemagglutination reaction "Shigella RPGA" according to TU 21.20.23-296-70423725-2021, with accessories Options: I. General set, consisting of: - Test-erythrocytes Flexner 1-5 (TE FL 1-5) - 1 bottle. (5.0 ml); - Test erythrocytes Flexner 6 (TE FL 6) - 1 bottle. (5.0 ml); - Sonne erythrocyte test (TE Sonne) - 1 vial. (5.0 ml); - Control erythrocytes EC - 1 vial. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (30 ml); - Control positive sample K+FL 1-5 - 1 fl. (0.25 ml); - Control positive sample K+FL 6 - 1 fl. (0.25 ml); - Control positive sample K+Zonne - 1 vial. (0.25 ml); - Control negative sample - K- - 1 fl. (0.25 ml); - Microtitration plate - 3 pcs. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. II. Flexner 1-5 set, consisting of: - Test-erythrocytes Flexner 1-5 (TE FL 1-5) - 1 bottle. (5.0 ml); - Control erythrocytes - EC - 1 fl. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (10 ml); - Control positive sample - K+FL 1-5 - 1 fl. (0.25 ml); - Control negative sample - K- - 1 fl. (0.25 ml); - Microtitration plate - 1 pc. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. III. Flexner 6 set, consisting of: - Test erythrocytes Flexner 6 (TE FL 6) - 1 bottle. (5.0 ml); - Control erythrocytes - EC - 1 fl. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (10 ml); - Control positive sample - K+FL 6 -1 fl. (0.25 ml); - Control negative sample - K- - 1 fl. (0.25 ml); - Microtitration plate - 1 pc. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. IV. Sonne's set, consisting of: - Sonne erythrocyte test (TE Sonne) - 1 vial. (5.0 ml); - Control erythrocytes - EC - 1 fl. (5.0 ml); - Solution for diluting samples - PPO - 1 fl. (10 ml); - Control positive sample - K+Zonne - 1 vial. (0.25 ml); - Control negative sample - K- -1 fl. (0.25 ml); - Microtitration plate - 1 pc. Accessories: - Auxiliary plastic (PVC) containers - 3 pcs. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number РЗН 2022/17953 and manufactured by ECOlab JSC. The device was registered on August 08, 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.