Reagent kit "Enzyme immunoassay test system for the quantitative determination of autoantibodies to thyroid peroxidase in blood serum (plasma)" "ELISA-at-TPO", according to TU 21.20.23-320-70423725-2022 Composed of: 1. Immunosorbent - 1 plate (12 strips). 2. Calibration samples (KP1-5) - 5 fl. (1.1 ml). 3. Control positive sample (K+) - 1 vial. (1.1 ml). 4. Conjugate - 1 vial. (14 ml). 5. Solution for dilution of the test samples (PPO) - 1 bottle. (50 ml). 6. 26-fold concentrate of washing solution [OR(x26)] - 1 bottle. (22 ml). 7. Indicator solution (RI) - 1 bottle. (14 ml). 8. Stop reagent - 1 bottle. (15 ml). 9. Tips for automatic pipettes - 16 pcs. Accessories: 1. Auxiliary plastic containers - 4 pcs. 2. Adhesive film for tablets - 4 pcs. - Roszdravnadzor Registration РЗН 2023/19538

Access comprehensive regulatory information for Reagent kit "Enzyme immunoassay test system for the quantitative determination of autoantibodies to thyroid peroxidase in blood serum (plasma)" "ELISA-at-TPO", according to TU 21.20.23-320-70423725-2022 Composed of: 1. Immunosorbent - 1 plate (12 strips). 2. Calibration samples (KP1-5) - 5 fl. (1.1 ml). 3. Control positive sample (K+) - 1 vial. (1.1 ml). 4. Conjugate - 1 vial. (14 ml). 5. Solution for dilution of the test samples (PPO) - 1 bottle. (50 ml). 6. 26-fold concentrate of washing solution [OR(x26)] - 1 bottle. (22 ml). 7. Indicator solution (RI) - 1 bottle. (14 ml). 8. Stop reagent - 1 bottle. (15 ml). 9. Tips for automatic pipettes - 16 pcs. Accessories: 1. Auxiliary plastic containers - 4 pcs. 2. Adhesive film for tablets - 4 pcs. 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 2023/19538 and manufactured by CJSC "ECOlab". The device was registered on February 07, 2023.

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.