"Reagent kit for the determination of α-amylase activity in serum, blood plasma and urine (Amylase)" according to TU 9398-576-23548172-2016 - Reagent 1 (P1); Configuration options: 1) - reagent: 5 vials (20 ml each); 2) - reagent: 4 vials (50 ml each); 3) - reagent: 5 vials (50 ml each); for the MIURA automatic analyzer; 4) - reagent: 12 vials (42 ml each); for the automatic analyzer ILab Taurus; 5) - reagent: 5 vials (60 ml each); for automatic analyzer BA400; 6) - reagent: 4 vials (52 ml each); for the Aspect Automatic Analyzer.
Russia·204430·JSC "Vector-Best"·Registered August 16, 2024·Class 2a- Device Name (English)
- "Reagent kit for the determination of α-amylase activity in serum, blood plasma and urine (Amylase)" according to TU 9398-576-23548172-2016 - Reagent 1 (P1); Configuration options: 1) - reagent: 5 vials (20 ml each); 2) - reagent: 4 vials (50 ml each); 3) - reagent: 5 vials (50 ml each); for the MIURA automatic analyzer; 4) - reagent: 12 vials (42 ml each); for the automatic analyzer ILab Taurus; 5) - reagent: 5 vials (60 ml each); for automatic analyzer BA400; 6) - reagent: 4 vials (52 ml each); for the Aspect Automatic Analyzer.
- Device Name (Russian)
- "Набор реагентов для определения активности α-амилазы в сыворотке, плазме крови и моче (Амилаза)" по ТУ 9398-576-23548172-2016 - реагент 1 (Р1); Состав вариантов комплектации: 1) - реагент: 5 флаконов (по 20 мл); 2) - реагент: 4 флакона (по 50 мл); 3) - реагент: 5 флаконов (по 50 мл); для автоматического анализатора MIURA; 4) - реагент: 12 флаконов (по 42 мл); для автоматического анализатора ILab Taurus; 5) - реагент: 5 флаконов (по 60 мл); для автоматического анализатора ВА400; 6) - реагент: 4 флакона (по 52 мл); для автоматического анализатора Aspect.
- Device Type (English)
- N/A
- Device Type (Russian)
- 204430
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 81011.0
- Registration Number
- РЗН 2017/6217
- 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, 630117, Novosibirsk, Pasechnaya str., 3. 2. JSC "Vector-Best", Russia, 630117, Novosibirsk, Arbuzova str., 1/1. 3. JSC "Vector-Best", Russia, 630559, Novosibirsk region, Koltsovo settlement, Research and Production Zone, room 36.
- Legal Address (Russian)
- 1. АО "Вектор-Бест", Россия, 630117, г. Новосибирск, ул. Пасечная, д. 3. 2. АО "Вектор-Бест", Россия, 630117, г. Новосибирск, ул. Арбузова, д. 1/1. 3. АО "Вектор-Бест", Россия, 630559, Новосибирская область, р.п. Кольцово, Научно-производственная зона, к. 36.
- 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 α-amylase activity in serum, blood plasma and urine (Amylase)" according to TU 9398-576-23548172-2016 - Reagent 1 (P1); Configuration options: 1) - reagent: 5 vials (20 ml each); 2) - reagent: 4 vials (50 ml each); 3) - reagent: 5 vials (50 ml each); for the MIURA automatic analyzer; 4) - reagent: 12 vials (42 ml each); for the automatic analyzer ILab Taurus; 5) - reagent: 5 vials (60 ml each); for automatic analyzer BA400; 6) - reagent: 4 vials (52 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 2017/6217 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.