Reagent kit for determining the activity of coagulation factor VIII by chromogenic method on automatic coagulogmeters "Technology Solution" (TS-Factor VIII chromo) according to TU 21.20.23-127-42349142-2023 Trim levels: I. Complete set No 1: 1. Factor X (freeze-dried), 2 fl per 2 ml. 2. Factor IXa (lyophilically dried), per 2 ml - 2 vials. 3. Chromogenic substrate (lyophilically dried), per 6 ml - 2 fl. 4. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. II. Configuration No 2: 1. Factor X (freeze-dried), 2 fl per 2 ml. 2. Factor IXa (lyophilically dried), per 2 ml - 2 vials. 3. Chromogenic substrate (lyophilically dried), per 1 ml - 2 fl. 4. Thinner for chromogenic substrate, 5 ml - 2 vials. 5. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. III. Configuration No 3: 1. Factor X (freeze-dried), per 1 ml - 1 fl. 2. Factor IXa (lyophilically dried), per 1 ml - 1 fl. 3. Chromogenic substrate (lyophilically dried), per 3 ml - 1 fl. 4. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. IV. Configuration No 4: 1. Factor X (freeze-dried), per 1 ml - 1 fl. 2. Factor IXa (lyophilically dried), per 1 ml - 1 fl. 3. Chromogenic substrate (lyophilically dried), per 0.5 ml - 1 fl. 4. Diluent for chromogenic substrate, 2.5 ml - 1 bottle. 5. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. The delivery set includes: reagent, instructions for use, passport.
Russia·297240·Technologia-Standard LLC·Registered July 08, 2024·Class 2a- Device Name (English)
- Reagent kit for determining the activity of coagulation factor VIII by chromogenic method on automatic coagulogmeters "Technology Solution" (TS-Factor VIII chromo) according to TU 21.20.23-127-42349142-2023 Trim levels: I. Complete set No 1: 1. Factor X (freeze-dried), 2 fl per 2 ml. 2. Factor IXa (lyophilically dried), per 2 ml - 2 vials. 3. Chromogenic substrate (lyophilically dried), per 6 ml - 2 fl. 4. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. II. Configuration No 2: 1. Factor X (freeze-dried), 2 fl per 2 ml. 2. Factor IXa (lyophilically dried), per 2 ml - 2 vials. 3. Chromogenic substrate (lyophilically dried), per 1 ml - 2 fl. 4. Thinner for chromogenic substrate, 5 ml - 2 vials. 5. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. III. Configuration No 3: 1. Factor X (freeze-dried), per 1 ml - 1 fl. 2. Factor IXa (lyophilically dried), per 1 ml - 1 fl. 3. Chromogenic substrate (lyophilically dried), per 3 ml - 1 fl. 4. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. IV. Configuration No 4: 1. Factor X (freeze-dried), per 1 ml - 1 fl. 2. Factor IXa (lyophilically dried), per 1 ml - 1 fl. 3. Chromogenic substrate (lyophilically dried), per 0.5 ml - 1 fl. 4. Diluent for chromogenic substrate, 2.5 ml - 1 bottle. 5. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. The delivery set includes: reagent, instructions for use, passport.
- Device Name (Russian)
- Набор реагентов для определения активности коагуляционного фактора VIII хромогенным методом на автоматических коагулометрах «Technology Solution» (ТS-Фактор VIII Хромо) по ТУ 21.20.23-127-42349142-2023 варианты комплектаций: I. Комплектация № 1: 1. Фактор Х (лиофильно высушенный), на 2 мл - 2 фл. 2. Фактор IХа (лиофильно высушенный), на 2 мл - 2 фл. 3. Хромогенный субстрат (лиофильно высушенный), на 6 мл - 2 фл. 4. Калибровочная плазма (лиофильно высушенная), на 1 мл - 1 фл. II. Комплектация № 2: 1. Фактор Х (лиофильно высушенный), на 2 мл - 2 фл. 2. Фактор IХа (лиофильно высушенный), на 2 мл - 2 фл. 3. Хромогенный субстрат (лиофильно высушенный), на 1 мл - 2 фл. 4. Разбавитель для хромогенного субстрата, 5 мл - 2 фл. 5. Калибровочная плазма (лиофильно высушенная), на 1 мл - 1 фл. III. Комплектация № 3: 1. Фактор Х (лиофильно высушенный), на 1 мл - 1 фл. 2. Фактор IХа (лиофильно высушенный), на 1 мл - 1 фл. 3. Хромогенный субстрат (лиофильно высушенный), на 3 мл - 1 фл. 4. Калибровочная плазма (лиофильно высушенная), на 1 мл - 1 фл. IV. Комплектация № 4: 1. Фактор Х (лиофильно высушенный), на 1 мл - 1 фл. 2. Фактор IХа (лиофильно высушенный), на 1 мл - 1 фл. 3. Хромогенный субстрат (лиофильно высушенный), на 0,5 мл - 1 фл. 4. Разбавитель для хромогенного субстрата, 2,5 мл - 1 фл. 5. Калибровочная плазма (лиофильно высушенная), на 1 мл - 1 фл. В комплект поставки входят: реагент, инструкция по применению, паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 297240
- Risk Class
- Class 2a
- OKPD Code
- 21.20.23.110
- Registry Key
- 78082.0
- Registration Number
- РЗН 2024/23087
- Registration Date
- July 08, 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 VIII by chromogenic method on automatic coagulogmeters "Technology Solution" (TS-Factor VIII chromo) according to TU 21.20.23-127-42349142-2023 Trim levels: I. Complete set No 1: 1. Factor X (freeze-dried), 2 fl per 2 ml. 2. Factor IXa (lyophilically dried), per 2 ml - 2 vials. 3. Chromogenic substrate (lyophilically dried), per 6 ml - 2 fl. 4. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. II. Configuration No 2: 1. Factor X (freeze-dried), 2 fl per 2 ml. 2. Factor IXa (lyophilically dried), per 2 ml - 2 vials. 3. Chromogenic substrate (lyophilically dried), per 1 ml - 2 fl. 4. Thinner for chromogenic substrate, 5 ml - 2 vials. 5. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. III. Configuration No 3: 1. Factor X (freeze-dried), per 1 ml - 1 fl. 2. Factor IXa (lyophilically dried), per 1 ml - 1 fl. 3. Chromogenic substrate (lyophilically dried), per 3 ml - 1 fl. 4. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. IV. Configuration No 4: 1. Factor X (freeze-dried), per 1 ml - 1 fl. 2. Factor IXa (lyophilically dried), per 1 ml - 1 fl. 3. Chromogenic substrate (lyophilically dried), per 0.5 ml - 1 fl. 4. Diluent for chromogenic substrate, 2.5 ml - 1 bottle. 5. Calibration plasma (lyophilically dried), per 1 ml - 1 fl. The delivery set includes: reagent, instructions for use, 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 2024/23087 and manufactured by Technologia-Standard LLC. The device was registered on July 08, 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.