Reagent kit for the determination of iron content in blood serum (IRON DDS) according to TU 21.20.23.110-003-48813770-2016 Options: 1. Option 1: 1.1. Reagent 1: buffer solution, pH 4.5; 1.2. Reagent 2: solution with ferrosine; 1.3. Calibrator: ferrous ferrous calibration solution, 17.9 μmol/l. in the following configurations: 1) Reagent 1: 4 vials (20 ml each); Reagent 2: 1 vial (20 ml); Calibrator: 2 vials (3.0 ml each). 2) Reagent 1: 5 vials (80 ml each); Reagent 2: 1 vial (100 ml); Calibrator: 4 vials (3.0 ml each). 3) Reagent 1: 2 vials (40 ml each); Reagent 2: 1 vial (20 ml); Calibrator: 1 vial (3.0 ml). 4) Reagent 1: 4 vials (40 ml each); Reagent 2: 2 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 5) Reagent 1: 4 vials (24 ml each); Reagent 2: 4 vials (8.0 ml each); Calibrator: 1 vial (3.0 ml). 6) Reagent 1: 4 vials (10 ml each); Reagent 2: 1 vial (10 mL); Calibrator: 1 vial (3.0 ml). 7) Reagent 1: 4 vials (90 ml each); Reagent 2: 1 vial (90 ml); Calibrator: 4 vials (3.0 ml each). 8) Reagent 1: 2 vials (68 ml each); Reagent 2: 2 vials (17 ml each); Calibrator: 1 vial (3.0 ml). 9) Reagent 1: 6 vials (68 ml each); Reagent 2: 6 vials (17 ml each); Calibrator: 2 vials (3.0 ml each). 10) Reagent 1: 2 vials (64 ml each); Reagent 2: 2 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 11) Reagent 1: 6 vials (64 ml each); Reagent 2: 6 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 12) Reagent 1: 2 vials (65 ml each); Reagent 2: 2 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 13) Reagent 1: 6 vials (65 ml each); Reagent 2: 6 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 14) Reagent 1: 4 vials (65 ml each); Reagent 2: 4 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 15) Reagent 1: 4 vials (38 ml each); Reagent 2: 2 vials (22 ml each); Calibrator: 1 vial (3.0 ml). 16) Reagent 1: 6 vials (24 ml each); Reagent 2: 3 vials (13 ml each); Calibrator: 1 vial (3.0 ml). 17) Reagent 1: 2 vials (62 ml each); Reagent 2: 2 vials (18 ml each); Calibrator: 1 vial (3.0 ml). 18) Reagent 1: 5 vials (62 ml each); Reagent 2: 5 vials (18 ml each); Calibrator: 1 vial (3.0 ml). 19) Reagent 1: 6 vials (20 ml each); Reagent 2: 6 vials (5.0 ml each); Calibrator: 1 vial (3.0 ml). 20) Reagent 1: 10 vials (40 ml each); Reagent 2: 2 vials (50 ml each); Calibrator: 1 vial (3.0 ml). 21) Reagent 1: 4 vials (60 ml each); Reagent 2: 1 vial (60 ml); Calibrator: 1 vial (3.0 ml). 22) Reagent 1: 4 vials (50 ml each); Reagent 2: 2 vials (25 ml each); Calibrator: 3 vials (3.0 ml each). 23) Reagent 1:1 canister (10000 ml); Reagent 2: 1 canister (2500 ml); Calibrator: 1 vial (500 ml). 24) Reagent 1: 4 vials (17 ml each); Reagent 2: 1 vial (18 ml); Calibrator: 1 vial (3.0 ml). 25) Reagent 1: 4 vials (31 ml each); Reagent 2: 2 vials (16 ml each); Calibrator: 1 vial (3.0 ml). 2. Option 2: 2.1. Reagent 1: buffer solution, pH 4.5; 2.2. Reagent 2: solution with ferrosine; 2.3. Calibrator: ferrous ferrous calibration solution, 17.9 μmol/l; 2.4. Identification Tag. in the following configurations: 1) Reagent 1: 4 vials (20 ml each); Reagent 2: 1 vial (20 ml); Calibrator: 2 vials (3.0 ml each); Identification Tag: 1 piece. 2) Reagent 1: 5 vials (80 ml each); Reagent 2: 1 vial (100 ml); Calibrator: 4 vials (3.0 ml each); Identification Tag: 1 piece. - Roszdravnadzor Registration ФСР 2008/02953
Access comprehensive regulatory information for Reagent kit for the determination of iron content in blood serum (IRON DDS) according to TU 21.20.23.110-003-48813770-2016 Options: 1. Option 1: 1.1. Reagent 1: buffer solution, pH 4.5; 1.2. Reagent 2: solution with ferrosine; 1.3. Calibrator: ferrous ferrous calibration solution, 17.9 μmol/l. in the following configurations: 1) Reagent 1: 4 vials (20 ml each); Reagent 2: 1 vial (20 ml); Calibrator: 2 vials (3.0 ml each). 2) Reagent 1: 5 vials (80 ml each); Reagent 2: 1 vial (100 ml); Calibrator: 4 vials (3.0 ml each). 3) Reagent 1: 2 vials (40 ml each); Reagent 2: 1 vial (20 ml); Calibrator: 1 vial (3.0 ml). 4) Reagent 1: 4 vials (40 ml each); Reagent 2: 2 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 5) Reagent 1: 4 vials (24 ml each); Reagent 2: 4 vials (8.0 ml each); Calibrator: 1 vial (3.0 ml). 6) Reagent 1: 4 vials (10 ml each); Reagent 2: 1 vial (10 mL); Calibrator: 1 vial (3.0 ml). 7) Reagent 1: 4 vials (90 ml each); Reagent 2: 1 vial (90 ml); Calibrator: 4 vials (3.0 ml each). 8) Reagent 1: 2 vials (68 ml each); Reagent 2: 2 vials (17 ml each); Calibrator: 1 vial (3.0 ml). 9) Reagent 1: 6 vials (68 ml each); Reagent 2: 6 vials (17 ml each); Calibrator: 2 vials (3.0 ml each). 10) Reagent 1: 2 vials (64 ml each); Reagent 2: 2 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 11) Reagent 1: 6 vials (64 ml each); Reagent 2: 6 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 12) Reagent 1: 2 vials (65 ml each); Reagent 2: 2 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 13) Reagent 1: 6 vials (65 ml each); Reagent 2: 6 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 14) Reagent 1: 4 vials (65 ml each); Reagent 2: 4 vials (20 ml each); Calibrator: 1 vial (3.0 ml). 15) Reagent 1: 4 vials (38 ml each); Reagent 2: 2 vials (22 ml each); Calibrator: 1 vial (3.0 ml). 16) Reagent 1: 6 vials (24 ml each); Reagent 2: 3 vials (13 ml each); Calibrator: 1 vial (3.0 ml). 17) Reagent 1: 2 vials (62 ml each); Reagent 2: 2 vials (18 ml each); Calibrator: 1 vial (3.0 ml). 18) Reagent 1: 5 vials (62 ml each); Reagent 2: 5 vials (18 ml each); Calibrator: 1 vial (3.0 ml). 19) Reagent 1: 6 vials (20 ml each); Reagent 2: 6 vials (5.0 ml each); Calibrator: 1 vial (3.0 ml). 20) Reagent 1: 10 vials (40 ml each); Reagent 2: 2 vials (50 ml each); Calibrator: 1 vial (3.0 ml). 21) Reagent 1: 4 vials (60 ml each); Reagent 2: 1 vial (60 ml); Calibrator: 1 vial (3.0 ml). 22) Reagent 1: 4 vials (50 ml each); Reagent 2: 2 vials (25 ml each); Calibrator: 3 vials (3.0 ml each). 23) Reagent 1:1 canister (10000 ml); Reagent 2: 1 canister (2500 ml); Calibrator: 1 vial (500 ml). 24) Reagent 1: 4 vials (17 ml each); Reagent 2: 1 vial (18 ml); Calibrator: 1 vial (3.0 ml). 25) Reagent 1: 4 vials (31 ml each); Reagent 2: 2 vials (16 ml each); Calibrator: 1 vial (3.0 ml). 2. Option 2: 2.1. Reagent 1: buffer solution, pH 4.5; 2.2. Reagent 2: solution with ferrosine; 2.3. Calibrator: ferrous ferrous calibration solution, 17.9 μmol/l; 2.4. Identification Tag. in the following configurations: 1) Reagent 1: 4 vials (20 ml each); Reagent 2: 1 vial (20 ml); Calibrator: 2 vials (3.0 ml each); Identification Tag: 1 piece. 2) Reagent 1: 5 vials (80 ml each); Reagent 2: 1 vial (100 ml); Calibrator: 4 vials (3.0 ml each); Identification Tag: 1 piece. in the Russia medical device market through Pure Global AI's free database. This Class 2a medical device is registered under Roszdravnadzor registration number ФСР 2008/02953 and manufactured by JSC "DIAKON-DS". The device was registered on October 04, 2022.
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.

