Reagent kit for determining the activity of coagulation factor IX in blood plasma (Tech-Factor IX-test) according to TU 21.20.23-128-42349142-2023 Composed of: 1. Factor IX deficient plasma (lyophilically dried, obtained by immunosorption), per 2 ml - 1 vial. 2. Plasma calibrator (freeze-dried), 1 fl per 1 ml. 3. APTV-reagent (solution containing phospholipids, ellagic acid, buffer and stabilizers), 2.5 ml - 1 fl. 4. Calcium chloride (0.277 %, 0.025 M solution), 10 ml - 1 vial. 5. Tris-HCl buffer (working solution), 10 ml - 1 vial. 6. Instructions for use. 7. Passport.
Russia·297030·Technologia-Standard LLC·Registered June 11, 2024·Class 2a- Device Name (English)
- Reagent kit for determining the activity of coagulation factor IX in blood plasma (Tech-Factor IX-test) according to TU 21.20.23-128-42349142-2023 Composed of: 1. Factor IX deficient plasma (lyophilically dried, obtained by immunosorption), per 2 ml - 1 vial. 2. Plasma calibrator (freeze-dried), 1 fl per 1 ml. 3. APTV-reagent (solution containing phospholipids, ellagic acid, buffer and stabilizers), 2.5 ml - 1 fl. 4. Calcium chloride (0.277 %, 0.025 M solution), 10 ml - 1 vial. 5. Tris-HCl buffer (working solution), 10 ml - 1 vial. 6. Instructions for use. 7. Passport.
- Device Name (Russian)
- Набор реагентов для определения активности коагуляционного фактора IX в плазме крови (Тех-Фактор IX-тест) по ТУ 21.20.23-128-42349142-2023 в составе: 1. Дефицитная по фактору IX плазма (лиофильно высушенная, полученная методом иммуносорбции), на 2 мл - 1 фл. 2. Плазма-калибратор (лиофильно высушенная), на 1 мл - 1 фл. 3. АПТВ-реагент (раствор, содержащий фосфолипиды, эллаговую кислоту, буфер и стабилизаторы), 2,5 мл - 1 фл. 4. Кальция хлорид (0,277 %, 0,025 М раствор), 10 мл - 1 фл. 5. Буфер трис-НСl (рабочий раствор), 10 мл - 1 фл. 6. Инструкция по применению. 7. Паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 297030
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78083.0
- Registration Number
- РЗН 2024/22904
- Registration Date
- June 11, 2024
- Manufacturer Name (English)
- Technologia-Standard LLC
- Manufacturer Name (Russian)
- ООО фирма "Технология-Стандарт"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- Technologia-Standard LLC, 116/95 Kalinina Ave., Barnaul, Altai Territory, 656037, Russia
- Legal Address (Russian)
- ООО фирма "Технология-Стандарт", Россия, 656037, Алтайский край, г. Барнаул, пр-кт Калинина, д. 116/95
- Manufacturing Address
- 656037, Россия, Алтайский край, г. Барнаул, пр-кт Калинина, д. 116/95
Access comprehensive regulatory information for Reagent kit for determining the activity of coagulation factor IX in blood plasma (Tech-Factor IX-test) according to TU 21.20.23-128-42349142-2023 Composed of: 1. Factor IX deficient plasma (lyophilically dried, obtained by immunosorption), per 2 ml - 1 vial. 2. Plasma calibrator (freeze-dried), 1 fl per 1 ml. 3. APTV-reagent (solution containing phospholipids, ellagic acid, buffer and stabilizers), 2.5 ml - 1 fl. 4. Calcium chloride (0.277 %, 0.025 M solution), 10 ml - 1 vial. 5. Tris-HCl buffer (working solution), 10 ml - 1 vial. 6. Instructions for use. 7. 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 2024/22904 and manufactured by Technologia-Standard LLC. The device was registered on June 11, 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.