Reagent kit for determining the concentration of direct bilirubin in blood serum by the dichloroaniline method (DIRECT BILIRUBIN DHA-OLVEX) according to TU 21.20.23-078-44276594-2022 Options: 1. Set No 1 (cat. No 003.008), consisting of: - Reagent 1 - 1 vial (80 ml); - Reagent 2 - 1 vial (20 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 2. Set No 2 (cat. No 003.018), consisting of: - Reagent 1 - 1 vial (200 ml); - Reagent 2 - 1 vial (50 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 3. Set No 3 (cat. No 003.028), consisting of: - Reagent 1 - 2 vials (200 ml each); - Reagent 2 - 2 vials (50 ml each); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport. - Roszdravnadzor Registration РЗН 2024/23031

Access comprehensive regulatory information for Reagent kit for determining the concentration of direct bilirubin in blood serum by the dichloroaniline method (DIRECT BILIRUBIN DHA-OLVEX) according to TU 21.20.23-078-44276594-2022 Options: 1. Set No 1 (cat. No 003.008), consisting of: - Reagent 1 - 1 vial (80 ml); - Reagent 2 - 1 vial (20 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 2. Set No 2 (cat. No 003.018), consisting of: - Reagent 1 - 1 vial (200 ml); - Reagent 2 - 1 vial (50 ml); - Calibrator (lyophilizate) - 1 vial; - Instructions for use; -Passport; 3. Set No 3 (cat. No 003.028), consisting of: - Reagent 1 - 2 vials (200 ml each); - Reagent 2 - 2 vials (50 ml each); - Calibrator (lyophilizate) - 1 vial; - 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 2024/23031 and manufactured by OLVEX DIAGNOSTICS LLC. The device was registered on July 02, 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.