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. - Roszdravnadzor Registration РЗН 2024/22904

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.