Reagent kit for determining the concentration of direct bilirubin in blood serum by the dichloroaniline method (DIRECT BILIRUBIN DHA-OLVEX) according to TU 21.20.23-078-44276594-2022 Options: 1. Set No 1 (cat. No 003.008), consisting of: - Reagent 1 - 1 vial (80 ml); - Reagent 2 - 1 vial (20 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 2. Set No 2 (cat. No 003.018), consisting of: - Reagent 1 - 1 vial (200 ml); - Reagent 2 - 1 vial (50 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 3. Set No 3 (cat. No 003.028), consisting of: - Reagent 1 - 2 vials (200 ml each); - Reagent 2 - 2 vials (50 ml each); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport.
Russia·296290·OLVEX DIAGNOSTICS LLC·Registered July 02, 2024·Class 2a- Device Name (English)
- Reagent kit for determining the concentration of direct bilirubin in blood serum by the dichloroaniline method (DIRECT BILIRUBIN DHA-OLVEX) according to TU 21.20.23-078-44276594-2022 Options: 1. Set No 1 (cat. No 003.008), consisting of: - Reagent 1 - 1 vial (80 ml); - Reagent 2 - 1 vial (20 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 2. Set No 2 (cat. No 003.018), consisting of: - Reagent 1 - 1 vial (200 ml); - Reagent 2 - 1 vial (50 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 3. Set No 3 (cat. No 003.028), consisting of: - Reagent 1 - 2 vials (200 ml each); - Reagent 2 - 2 vials (50 ml each); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport.
- Device Name (Russian)
- Набор реагентов для определения концентрации прямого билирубина в сыворотке крови дихлоранилиновым методом (ПРЯМОЙ БИЛИРУБИН ДХА-ОЛЬВЕКС) по ТУ 21.20.23-078-44276594-2022 , варианты исполнения: 1. Комплект № 1 (кат. № 003.008), в составе: - Реагент 1 - 1 флакон (80 мл); - Реагент 2 - 1 флакон (20 мл); - Калибратор (лиофилизат) - 1 флакон; - Инструкция по применению; - Паспорт; 2. Комплект № 2 (кат. № 003.018), в составе: - Реагент 1 - 1 флакон (200 мл); - Реагент 2 - 1 флакон (50 мл); - Калибратор (лиофилизат) - 1 флакон; - Инструкция по применению; - Паспорт; 3. Комплект № 3 (кат. № 003.028), в составе: - Реагент 1 - 2 флакона (по 200 мл); - Реагент 2 - 2 флакона (по 50 мл); - Калибратор (лиофилизат) - 1 флакон; - Инструкция по применению; - Паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 296290
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 79117.0
- Registration Number
- РЗН 2024/23031
- Registration Date
- July 02, 2024
- Manufacturer Name (English)
- OLVEX DIAGNOSTICS LLC
- Manufacturer Name (Russian)
- ООО "ОЛЬВЕКС ДИАГНОСТИКУМ"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- OLVEX DIAGNOSTICUM LLC, 10/1/1/1, Oktyabrskaya Embankment, St. Petersburg, 192029, Russia
- Legal Address (Russian)
- ООО "ОЛЬВЕКС ДИАГНОСТИКУМ", Россия, 192029, г. Санкт-Петербург, наб. Октябрьская, д. 10, к. 1, стр. 1
- Manufacturing Address
- 199155, Россия, Санкт-Петербург, пер. Декабристов, д. 5/17, помещ. 1
Access comprehensive regulatory information for Reagent kit for determining the concentration of direct bilirubin in blood serum by the dichloroaniline method (DIRECT BILIRUBIN DHA-OLVEX) according to TU 21.20.23-078-44276594-2022 Options: 1. Set No 1 (cat. No 003.008), consisting of: - Reagent 1 - 1 vial (80 ml); - Reagent 2 - 1 vial (20 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 2. Set No 2 (cat. No 003.018), consisting of: - Reagent 1 - 1 vial (200 ml); - Reagent 2 - 1 vial (50 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 3. Set No 3 (cat. No 003.028), consisting of: - Reagent 1 - 2 vials (200 ml each); - Reagent 2 - 2 vials (50 ml each); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -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 2024/23031 and manufactured by OLVEX DIAGNOSTICS LLC. The device was registered on July 02, 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.