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. - Roszdravnadzor Registration РЗН 2024/23087

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.