Reagent kit for determining the concentration of creatinine in blood serum (plasma) and urine by the kinetic method based on the Jaffe reaction ("CREATININE ABRIS+") according to TU 21.20.23-107-27428909-2023 Options: 1. Complete set No 1, consisting of: - Reagent 1 - 1 vial (25 ml); - Reagent 2 - 1 vial (25 ml); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 2. Complete set No 2, consisting of: - Reagent 1 - 1 vial (50 ml); - Reagent 2 - 1 vial (50 ml); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 3. Configuration No 3, consisting of: - Reagent 1 - 1 vial (100 ml); - Reagent 2 - 1 vial (100 ml); - Calibrator - 1 vial (5 ml). The delivery set includes instructions for use and a passport. 4. Complete set No 4, consisting of: - Reagent 1 - 1 vial (250 ml); - Reagent 2 - 1 vial (250 ml); - Calibrator - 1 vial (5 ml). The delivery set includes instructions for use and a passport. 5. Complete set No 5, consisting of: - Reagent 1 - 4 vials (15 ml each); - Reagent 2 - 4 vials (15 ml each); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 6. Complete set No 6, consisting of: - Reagent 1 - 1 vial (40 ml); - Reagent 2 - 3 vials (14 ml each); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 7. Complete set No 7, consisting of: - Reagent 1 - 2 vials (40 ml each); - Reagent 2 - 6 vials (14 ml each); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport.
Russia·284650·NPF ABRIS+ LLC·Registered June 28, 2024·Class 2a- Device Name (English)
- Reagent kit for determining the concentration of creatinine in blood serum (plasma) and urine by the kinetic method based on the Jaffe reaction ("CREATININE ABRIS+") according to TU 21.20.23-107-27428909-2023 Options: 1. Complete set No 1, consisting of: - Reagent 1 - 1 vial (25 ml); - Reagent 2 - 1 vial (25 ml); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 2. Complete set No 2, consisting of: - Reagent 1 - 1 vial (50 ml); - Reagent 2 - 1 vial (50 ml); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 3. Configuration No 3, consisting of: - Reagent 1 - 1 vial (100 ml); - Reagent 2 - 1 vial (100 ml); - Calibrator - 1 vial (5 ml). The delivery set includes instructions for use and a passport. 4. Complete set No 4, consisting of: - Reagent 1 - 1 vial (250 ml); - Reagent 2 - 1 vial (250 ml); - Calibrator - 1 vial (5 ml). The delivery set includes instructions for use and a passport. 5. Complete set No 5, consisting of: - Reagent 1 - 4 vials (15 ml each); - Reagent 2 - 4 vials (15 ml each); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 6. Complete set No 6, consisting of: - Reagent 1 - 1 vial (40 ml); - Reagent 2 - 3 vials (14 ml each); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 7. Complete set No 7, consisting of: - Reagent 1 - 2 vials (40 ml each); - Reagent 2 - 6 vials (14 ml each); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport.
- Device Name (Russian)
- Набор реагентов для определения концентрации креатинина в сыворотке (плазме) крови и моче кинетическим методом на основе реакции Яффе ("КРЕАТИНИН АБРИС+") по ТУ 21.20.23-107-27428909-2023 , варианты исполнения: 1. Комплектация № 1 , в составе: - Реагент 1 - 1 флакон (25 мл); - Реагент 2 - 1 флакон (25 мл); - Калибратор - 1 флакон (2 мл). В комплект поставки входит инструкция по применению и паспорт. 2. Комплектация № 2 , в составе: - Реагент 1 - 1 флакон (50 мл); - Реагент 2 - 1 флакон (50 мл); - Калибратор - 1 флакон (2 мл). В комплект поставки входит инструкция по применению и паспорт. 3. Комплектация № 3 , в составе: - Реагент 1 - 1 флакон (100 мл); - Реагент 2 - 1 флакон (100 мл); - Калибратор - 1 флакон (5 мл). В комплект поставки входит инструкция по применению и паспорт. 4. Комплектация № 4 , в составе: - Реагент 1 - 1 флакон (250 мл); - Реагент 2 - 1 флакон (250 мл); - Калибратор - 1 флакон (5 мл). В комплект поставки входит инструкция по применению и паспорт . 5. Комплектация № 5 , в составе: - Реагент 1 - 4 флакона (по 15 мл); - Реагент 2 - 4 флакона (по 15 мл); - Калибратор - 1 флакон (2 мл). В комплект поставки входит инструкция по применению и паспорт. 6. Комплектация № 6 , в составе: - Реагент 1 - 1 флакон (40 мл); - Реагент 2 - 3 флакона (по 14 мл); - Калибратор - 1 флакон (2 мл). В комплект поставки в ходит инструкция по применению и паспорт. 7. Комплектация № 7 , в составе: - Реагент 1 - 2 флакона (по 40 мл); - Реагент 2 - 6 флаконов (по 14 мл); - Калибратор - 1 флакон (2 мл). В комплект поставки входит инструкция по применению и паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 284650
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 79127.0
- Registration Number
- РЗН 2024/23004
- Registration Date
- June 28, 2024
- Manufacturer Name (English)
- NPF ABRIS+ LLC
- Manufacturer Name (Russian)
- ООО "НПФ "АБРИС+"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- NPF ABRIS+ LLC, St. Petersburg, 192019, Russia, Professor Kachalova str., 15a, lit. And
- Legal Address (Russian)
- ООО "НПФ "АБРИС+", Россия, 192019, Санкт-Петербург, ул. Профессора Качалова, д. 15а, лит. А
- Manufacturing Address
- 196006, Россия, Санкт-Петербург, ул. Цветочная, д. 16, лит. М, эт. 2
Access comprehensive regulatory information for Reagent kit for determining the concentration of creatinine in blood serum (plasma) and urine by the kinetic method based on the Jaffe reaction ("CREATININE ABRIS+") according to TU 21.20.23-107-27428909-2023 Options: 1. Complete set No 1, consisting of: - Reagent 1 - 1 vial (25 ml); - Reagent 2 - 1 vial (25 ml); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 2. Complete set No 2, consisting of: - Reagent 1 - 1 vial (50 ml); - Reagent 2 - 1 vial (50 ml); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 3. Configuration No 3, consisting of: - Reagent 1 - 1 vial (100 ml); - Reagent 2 - 1 vial (100 ml); - Calibrator - 1 vial (5 ml). The delivery set includes instructions for use and a passport. 4. Complete set No 4, consisting of: - Reagent 1 - 1 vial (250 ml); - Reagent 2 - 1 vial (250 ml); - Calibrator - 1 vial (5 ml). The delivery set includes instructions for use and a passport. 5. Complete set No 5, consisting of: - Reagent 1 - 4 vials (15 ml each); - Reagent 2 - 4 vials (15 ml each); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 6. Complete set No 6, consisting of: - Reagent 1 - 1 vial (40 ml); - Reagent 2 - 3 vials (14 ml each); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a passport. 7. Complete set No 7, consisting of: - Reagent 1 - 2 vials (40 ml each); - Reagent 2 - 6 vials (14 ml each); - Calibrator - 1 vial (2 ml). The delivery set includes instructions for use and a 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 2024/23004 and manufactured by NPF ABRIS+ LLC. The device was registered on June 28, 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.