Reagent kit for determining the concentration of D-dimer in blood plasma by the immunoturbidimetric method "D-DIMER-VITAL" according to TU 21.20.23-118-94568735-2022 Options: 1. Set 1, consisting of: - reagent 1 - 1 vial (15 ml); - Reagent 2 - 1 vial (5 ml). 2. Set 2, consisting of: - reagent 1 - 1 vial (30 ml); - reagent 2 - 1 vial (10 ml); - calibrator - 1 vial. 3. Set 3, consisting of: - reagent 1 - 1 vial (30 ml); - Reagent 2 - 1 vial (10 ml). 4. Set 4, consisting of: - reagent 1 - 2 vials (30 ml each); - reagent 2 - 2 vials (10 ml each). 5. Set 5, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (13 ml). 6. Set 6, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (7 ml). 7. Set 7, consisting of: - reagent 1 - 2 vials (20 ml each); - reagent 2 - 2 vials (11 ml each). 8. Set 8, consisting of: - reagent 1 - 2 vials (27 ml each); - reagent 2 - 2 vials (14 ml each). 9. Set 9, consisting of: - reagent 1 - 2 vials (30 ml each); - reagent 2 - 2 vials (15 ml each). 10. Set 10, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (7 ml). - calibrator - 1 vial. 11. Set 11, consisting of: - reagent 1 - 1 vial (40 ml); - Reagent 2 - 1 vial (15 ml). 12. Set 12, consisting of: - reagent 1 - 1 vial (40 ml); - reagent 2 - 1 vial (15 ml); - calibrator - 1 vial. 13. Set 13, consisting of: - reagent 1 - 1 vial (26 ml); - Reagent 2 - 1 vial (9 ml). 14. Set 14, consisting of: - reagent 1 - 2 vials (25 ml each); - reagent 2 - 2 vials (8.5 ml each). 15. Set 15, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (7.5 ml).
Russia·343160·Vital Development Corporation JSC·Registered September 18, 2023·Class 2a- Device Name (English)
- Reagent kit for determining the concentration of D-dimer in blood plasma by the immunoturbidimetric method "D-DIMER-VITAL" according to TU 21.20.23-118-94568735-2022 Options: 1. Set 1, consisting of: - reagent 1 - 1 vial (15 ml); - Reagent 2 - 1 vial (5 ml). 2. Set 2, consisting of: - reagent 1 - 1 vial (30 ml); - reagent 2 - 1 vial (10 ml); - calibrator - 1 vial. 3. Set 3, consisting of: - reagent 1 - 1 vial (30 ml); - Reagent 2 - 1 vial (10 ml). 4. Set 4, consisting of: - reagent 1 - 2 vials (30 ml each); - reagent 2 - 2 vials (10 ml each). 5. Set 5, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (13 ml). 6. Set 6, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (7 ml). 7. Set 7, consisting of: - reagent 1 - 2 vials (20 ml each); - reagent 2 - 2 vials (11 ml each). 8. Set 8, consisting of: - reagent 1 - 2 vials (27 ml each); - reagent 2 - 2 vials (14 ml each). 9. Set 9, consisting of: - reagent 1 - 2 vials (30 ml each); - reagent 2 - 2 vials (15 ml each). 10. Set 10, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (7 ml). - calibrator - 1 vial. 11. Set 11, consisting of: - reagent 1 - 1 vial (40 ml); - Reagent 2 - 1 vial (15 ml). 12. Set 12, consisting of: - reagent 1 - 1 vial (40 ml); - reagent 2 - 1 vial (15 ml); - calibrator - 1 vial. 13. Set 13, consisting of: - reagent 1 - 1 vial (26 ml); - Reagent 2 - 1 vial (9 ml). 14. Set 14, consisting of: - reagent 1 - 2 vials (25 ml each); - reagent 2 - 2 vials (8.5 ml each). 15. Set 15, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (7.5 ml).
- Device Name (Russian)
- Набор реагентов для определения концентрации D-димера в плазме крови иммунотурбидиметрическим методом "D-ДИМЕР-ВИТАЛ" по ТУ 21.20.23-118-94568735-2022 , варианты исполнения: 1. Комплект 1, в составе: - реагент 1 - 1 флакон (15 мл); - реагент 2 - 1 флакон (5 мл). 2. Комплект 2, в составе: - реагент 1 - 1 флакон (30 мл); - реагент 2 - 1 флакон (10 мл); - калибратор - 1 флакон. 3. Комплект 3, в составе: - реагент 1 - 1 флакон (30 мл); - реагент 2 - 1 флакон (10 мл). 4. Комплект 4, в составе: - реагент 1 - 2 флакона (по 30 мл); - реагент 2 - 2 флакона (по 10 мл). 5. Комплект 5, в составе: - реагент 1 - 1 флакон (20 мл); - реагент 2 - 1 флакон (13 мл). 6. Комплект 6, в составе: - реагент 1 - 1 флакон (20 мл); - реагент 2 - 1 флакон (7 мл). 7. Комплект 7, в составе: - реагент 1 - 2 флакона (по 20 мл); - реагент 2 - 2 флакона (по 11 мл). 8. Комплект 8, в составе: - реагент 1 - 2 флакона (по 27 мл); - реагент 2 - 2 флакона (по 14 мл). 9. Комплект 9, в составе: - реагент 1 - 2 флакона (по 30 мл); - реагент 2 - 2 флакона (по 15 мл). 10. Комплект 10, в составе: - реагент 1 - 1 флакон (20 мл); - реагент 2 - 1 флакон (7 мл). - калибратор - 1 флакон. 11. Комплект 11, в составе: - реагент 1 - 1 флакон (40 мл); - реагент 2 - 1 флакон (15 мл). 12. Комплект 12, в составе: - реагент 1 - 1 флакон (40 мл); - реагент 2 - 1 флакон (15 мл); - калибратор - 1 флакон. 13. Комплект 13, в составе: - реагент 1 - 1 флакон (26 мл); - реагент 2 - 1 флакон (9 мл). 14. Комплект 14, в составе: - реагент 1 - 2 флакона (по 25 мл); - реагент 2 - 2 флакона (по 8,5 мл). 15. Комплект 15, в составе: - реагент 1 - 1 флакон (20 мл); - реагент 2 - 1 флакон (7,5 мл).
- Device Type (English)
- N/A
- Device Type (Russian)
- 343160
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 73347.0
- Registration Number
- РЗН 2023/21080
- Registration Date
- September 18, 2023
- Manufacturer Name (English)
- Vital Development Corporation JSC
- Manufacturer Name (Russian)
- АО "Витал Девелопмент Корпорэйшн"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- JSC "Vital Development Corporation", Russia, 194356, St. Petersburg, Road to Kamenka, 56, lit. And
- Legal Address (Russian)
- АО "Витал Девелопмент Корпорэйшн", Россия, 194356, Санкт-Петербург, Дорога в Каменку, д. 56, лит. А
- Manufacturing Address
- 194356, Россия, Санкт-Петербург, Дорога в Каменку, д. 56, лит. А
Access comprehensive regulatory information for Reagent kit for determining the concentration of D-dimer in blood plasma by the immunoturbidimetric method "D-DIMER-VITAL" according to TU 21.20.23-118-94568735-2022 Options: 1. Set 1, consisting of: - reagent 1 - 1 vial (15 ml); - Reagent 2 - 1 vial (5 ml). 2. Set 2, consisting of: - reagent 1 - 1 vial (30 ml); - reagent 2 - 1 vial (10 ml); - calibrator - 1 vial. 3. Set 3, consisting of: - reagent 1 - 1 vial (30 ml); - Reagent 2 - 1 vial (10 ml). 4. Set 4, consisting of: - reagent 1 - 2 vials (30 ml each); - reagent 2 - 2 vials (10 ml each). 5. Set 5, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (13 ml). 6. Set 6, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (7 ml). 7. Set 7, consisting of: - reagent 1 - 2 vials (20 ml each); - reagent 2 - 2 vials (11 ml each). 8. Set 8, consisting of: - reagent 1 - 2 vials (27 ml each); - reagent 2 - 2 vials (14 ml each). 9. Set 9, consisting of: - reagent 1 - 2 vials (30 ml each); - reagent 2 - 2 vials (15 ml each). 10. Set 10, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (7 ml). - calibrator - 1 vial. 11. Set 11, consisting of: - reagent 1 - 1 vial (40 ml); - Reagent 2 - 1 vial (15 ml). 12. Set 12, consisting of: - reagent 1 - 1 vial (40 ml); - reagent 2 - 1 vial (15 ml); - calibrator - 1 vial. 13. Set 13, consisting of: - reagent 1 - 1 vial (26 ml); - Reagent 2 - 1 vial (9 ml). 14. Set 14, consisting of: - reagent 1 - 2 vials (25 ml each); - reagent 2 - 2 vials (8.5 ml each). 15. Set 15, consisting of: - reagent 1 - 1 vial (20 ml); - Reagent 2 - 1 vial (7.5 ml). 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 2023/21080 and manufactured by Vital Development Corporation JSC. The device was registered on September 18, 2023.
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.