Reagent kit for the determination of aspartate aminotransferase activity in blood serum and plasma by the kinetic UV method (AST IFCC) according to TU 9398-575-23548172-2016 - Reagent 1 (P1); - Reagent 2 (P2); Configuration options: 1) - reagent 1 - 2 vials (40 ml each); - reagent 2 - 2 vials (10 ml each); 2) - reagent 1 - 2 vials (200 ml each); - reagent 2 - 2 vials (50 ml each); 3) - reagent 1 - 4 vials (48 ml each); - reagent 2 - 4 vials (14 ml each); for the MIURA automatic analyzer; 4) - reagent 1 - 10 vials (78 ml each); - reagent 2 - 5 vials (42 ml each); for the automatic analyzer ILab Taurus; 5) - reagent 1 - 8 vials (60 ml each); - reagent 2 - 6 vials (20 ml each); for automatic analyzer BA400; 6) - reagent 1 - 12 vials (52 ml each); - reagent 2 - 12 vials (15 ml each); for the Aspect Automatic Analyzer.
Russia·204540·JSC "Vector-Best"·Registered August 16, 2024·Class 2a- Device Name (English)
- Reagent kit for the determination of aspartate aminotransferase activity in blood serum and plasma by the kinetic UV method (AST IFCC) according to TU 9398-575-23548172-2016 - Reagent 1 (P1); - Reagent 2 (P2); Configuration options: 1) - reagent 1 - 2 vials (40 ml each); - reagent 2 - 2 vials (10 ml each); 2) - reagent 1 - 2 vials (200 ml each); - reagent 2 - 2 vials (50 ml each); 3) - reagent 1 - 4 vials (48 ml each); - reagent 2 - 4 vials (14 ml each); for the MIURA automatic analyzer; 4) - reagent 1 - 10 vials (78 ml each); - reagent 2 - 5 vials (42 ml each); for the automatic analyzer ILab Taurus; 5) - reagent 1 - 8 vials (60 ml each); - reagent 2 - 6 vials (20 ml each); for automatic analyzer BA400; 6) - reagent 1 - 12 vials (52 ml each); - reagent 2 - 12 vials (15 ml each); for the Aspect Automatic Analyzer.
- Device Name (Russian)
- Набор реагентов для определения активности аспартатаминотрансферазы в сыворотке и плазме крови кинетическим УФ-методом (АСТ IFCC) по ТУ 9398-575-23548172-2016 - реагент 1 (Р1); - реагент 2 (Р2); Состав вариантов комплектации: 1) - реагент 1 - 2 флакона (по 40 мл); - реагент 2 - 2 флакона (по 10 мл); 2) - реагент 1 - 2 флакона (по 200 мл); - реагент 2 - 2 флакона (по 50 мл); 3) - реагент 1 - 4 флакона (по 48 мл); - реагент 2 - 4 флакона (по 14 мл); для автоматического анализатора MIURA; 4) - реагент 1 - 10 флаконов (по 78 мл); - реагент 2 - 5 флаконов (по 42 мл); для автоматического анализатора ILab Taurus; 5) - реагент 1 - 8 флаконов (по 60 мл); - реагент 2 - 6 флаконов (по 20 мл); для автоматического анализатора ВА400; 6) - реагент 1 - 12 флаконов (по 52 мл); - реагент 2 - 12 флаконов (по 15 мл); для автоматического анализатора Aspect.
- Device Type (English)
- N/A
- Device Type (Russian)
- 204540
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 80907.0
- Registration Number
- РЗН 2017/6208
- Registration Date
- August 16, 2024
- Manufacturer Name (English)
- JSC "Vector-Best"
- Manufacturer Name (Russian)
- АО "Вектор-Бест"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. JSC "Vector-Best", Russia, 630559, Novosibirsk region, Koltsovo settlement, Research and Production Zone, room 36. 2. JSC "Vector-Best", Russia, 630117, Novosibirsk, Pasechnaya str., 3. 3. JSC "Vector-Best", Russia, 630117, Novosibirsk, Arbuzova str., 1/1.
- Legal Address (Russian)
- 1. АО "Вектор-Бест", Россия, 630559, Новосибирская область, р. п. Кольцово, Научно-производственная зона, к. 36. 2. АО "Вектор-Бест", Россия, 630117, г. Новосибирск, ул. Пасечная, д. 3. 3. АО "Вектор-Бест", Россия, 630117, г. Новосибирск, ул. Арбузова, д. 1/1.
- Manufacturing Address
- 630559, Россия, Новосибирская область, р. п. Кольцово, Научно-производственная зона, к. 36, ком. 211
Access comprehensive regulatory information for Reagent kit for the determination of aspartate aminotransferase activity in blood serum and plasma by the kinetic UV method (AST IFCC) according to TU 9398-575-23548172-2016 - Reagent 1 (P1); - Reagent 2 (P2); Configuration options: 1) - reagent 1 - 2 vials (40 ml each); - reagent 2 - 2 vials (10 ml each); 2) - reagent 1 - 2 vials (200 ml each); - reagent 2 - 2 vials (50 ml each); 3) - reagent 1 - 4 vials (48 ml each); - reagent 2 - 4 vials (14 ml each); for the MIURA automatic analyzer; 4) - reagent 1 - 10 vials (78 ml each); - reagent 2 - 5 vials (42 ml each); for the automatic analyzer ILab Taurus; 5) - reagent 1 - 8 vials (60 ml each); - reagent 2 - 6 vials (20 ml each); for automatic analyzer BA400; 6) - reagent 1 - 12 vials (52 ml each); - reagent 2 - 12 vials (15 ml each); for the Aspect Automatic Analyzer. 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 2017/6208 and manufactured by JSC "Vector-Best". The device was registered on August 16, 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.