Reagent kit for the determination of aspartate aminotransferase activity in serum and plasma by the optimized enzymatic kinetic method "ACT UV-KINETICS ABRIS+" as per TU 21.20.23-106-27428909-2023 Composed of: I. Variants of execution: 1. Complete set No 1, consisting of: - reagent 1 - 1 vial (40 ml); - Reagent 2 - 1 vial (10 ml). 2. Complete set No 2, consisting of: - reagent 1 - 1 vial (80 ml); - Reagent 2 - 1 vial (20 ml). 3. Complete set No 3, consisting of: - reagent 1 - 5 vials (16 ml each); - Reagent 2 - 5 vials (4 ml each). 4. Configuration No 4, consisting of: - reagent 1 - 5 vials (40 ml each); - Reagent 2 - 5 vials (10 ml each). 5. Complete set No 5, consisting of: - reagent 1 - 2 vials (200 ml each); - reagent 2 - 2 vials (50 ml each). 6. Configuration No 6, consisting of: - reagent 1 - 3 vials (200 ml each); - reagent 2 - 3 vials (50 ml each). 7. Configuration No 7, consisting of: - reagent 1 - 6 vials (16 ml each); - Reagent 2 - 2 vials (12 ml each). 8. Complete set No 8, consisting of: - reagent 1 - 2 vials (40 ml each); - Reagent 2 - 1 vial (20 ml). 9. Configuration No 9, consisting of: - reagent 1 - 4 vials (40 ml each); - reagent 2 - 2 vials (20 ml each). 10. Configuration No 10, consisting of: - reagent 1 - 2 vials (50 ml each); - Reagent 2 (lyophilizate) - 2 vials. II. Instructions for use. III. Passport.
Russia·204540·NPF ABRIS+ LLC·Registered April 27, 2024·Class 2a- Device Name (English)
- Reagent kit for the determination of aspartate aminotransferase activity in serum and plasma by the optimized enzymatic kinetic method "ACT UV-KINETICS ABRIS+" as per TU 21.20.23-106-27428909-2023 Composed of: I. Variants of execution: 1. Complete set No 1, consisting of: - reagent 1 - 1 vial (40 ml); - Reagent 2 - 1 vial (10 ml). 2. Complete set No 2, consisting of: - reagent 1 - 1 vial (80 ml); - Reagent 2 - 1 vial (20 ml). 3. Complete set No 3, consisting of: - reagent 1 - 5 vials (16 ml each); - Reagent 2 - 5 vials (4 ml each). 4. Configuration No 4, consisting of: - reagent 1 - 5 vials (40 ml each); - Reagent 2 - 5 vials (10 ml each). 5. Complete set No 5, consisting of: - reagent 1 - 2 vials (200 ml each); - reagent 2 - 2 vials (50 ml each). 6. Configuration No 6, consisting of: - reagent 1 - 3 vials (200 ml each); - reagent 2 - 3 vials (50 ml each). 7. Configuration No 7, consisting of: - reagent 1 - 6 vials (16 ml each); - Reagent 2 - 2 vials (12 ml each). 8. Complete set No 8, consisting of: - reagent 1 - 2 vials (40 ml each); - Reagent 2 - 1 vial (20 ml). 9. Configuration No 9, consisting of: - reagent 1 - 4 vials (40 ml each); - reagent 2 - 2 vials (20 ml each). 10. Configuration No 10, consisting of: - reagent 1 - 2 vials (50 ml each); - Reagent 2 (lyophilizate) - 2 vials. II. Instructions for use. III. Passport.
- Device Name (Russian)
- Набор реагентов для определения активности аспартатаминотрансферазы в сыворотке и плазме крови оптимизированным энзиматическим кинетическим методом "ACT UV-КИНЕТИКА АБРИС+" по ТУ 21.20.23-106-27428909-2023 в составе: I. Варианты исполнения: 1. Комплектация № 1, в составе: - реагент 1 - 1 флакон (40 мл); - реагент 2 - 1 флакон (10 мл). 2. Комплектация № 2, в составе: - реагент 1 - 1 флакон (80 мл); - реагент 2 - 1 флакон (20 мл). 3. Комплектация № 3, в составе: - реагент 1 - 5 флаконов (по 16 мл); - реагент 2 - 5 флаконов (по 4 мл). 4. Комплектация № 4, в составе: - реагент 1 - 5 флаконов (по 40 мл); - реагент 2 - 5 флаконов (по 10 мл). 5. Комплектация № 5, в составе: - реагент 1 - 2 флакона (по 200 мл); - реагент 2 - 2 флакона (по 50 мл). 6. Комплектация № 6, в составе: - реагент 1 - 3 флакона (по 200 мл); - реагент 2 - 3 флакона (по 50 мл). 7. Комплектация № 7, в составе: - реагент 1 - 6 флаконов (по 16 мл); - реагент 2 - 2 флакона (по 12 мл). 8. Комплектация № 8, в составе: - реагент 1 - 2 флакона (по 40 мл); - реагент 2 - 1 флакон (20 мл). 9. Комплектация № 9, в составе: - реагент 1 - 4 флакона (по 40 мл); - реагент 2 - 2 флакона (по 20 мл). 10. Комплектация № 10, в составе: - реагент 1 - 2 флакона (по 50 мл); - реагент 2 (лиофилизат) - 2 флакона. II. Инструкция по применению . III. Паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 204540
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 77778.0
- Registration Number
- РЗН 2024/22509
- Registration Date
- April 27, 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 the determination of aspartate aminotransferase activity in serum and plasma by the optimized enzymatic kinetic method "ACT UV-KINETICS ABRIS+" as per TU 21.20.23-106-27428909-2023 Composed of: I. Variants of execution: 1. Complete set No 1, consisting of: - reagent 1 - 1 vial (40 ml); - Reagent 2 - 1 vial (10 ml). 2. Complete set No 2, consisting of: - reagent 1 - 1 vial (80 ml); - Reagent 2 - 1 vial (20 ml). 3. Complete set No 3, consisting of: - reagent 1 - 5 vials (16 ml each); - Reagent 2 - 5 vials (4 ml each). 4. Configuration No 4, consisting of: - reagent 1 - 5 vials (40 ml each); - Reagent 2 - 5 vials (10 ml each). 5. Complete set No 5, consisting of: - reagent 1 - 2 vials (200 ml each); - reagent 2 - 2 vials (50 ml each). 6. Configuration No 6, consisting of: - reagent 1 - 3 vials (200 ml each); - reagent 2 - 3 vials (50 ml each). 7. Configuration No 7, consisting of: - reagent 1 - 6 vials (16 ml each); - Reagent 2 - 2 vials (12 ml each). 8. Complete set No 8, consisting of: - reagent 1 - 2 vials (40 ml each); - Reagent 2 - 1 vial (20 ml). 9. Configuration No 9, consisting of: - reagent 1 - 4 vials (40 ml each); - reagent 2 - 2 vials (20 ml each). 10. Configuration No 10, consisting of: - reagent 1 - 2 vials (50 ml each); - Reagent 2 (lyophilizate) - 2 vials. II. Instructions for use. III. 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 2024/22509 and manufactured by NPF ABRIS+ LLC. The device was registered on April 27, 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.