Reagent kit "Enzyme immunoassay test system for the detection of class M immunoglobulins to respiratory syncytial virus" "ELISA-PCB-IgM" as per TU 9398-220-70423725-2016 Composed of: 1. Immunosorbent - 1 tablet. 2. Control positive sample (K+) - 1 vial. (1.2 ml). 3. Control sample of the level of "slice" (K + por) - 1 fl. (1.2 ml). 4. Control negative sample (K-) - 1 fl. (1.2 ml). 5. Conjugate - 1 fl. (13 ml). 6. Solution for diluting samples (PPO) - 1 bottle. (15 ml). 7. Solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml). 8. Blocking solution (BR) - 1 bottle. (7.5 ml). 9. 25-fold concentrate of flushing solution (PR (x25)) - 2 fl. (40 ml each). 10. Indicator solution (RI) - 1 bottle. (13 ml). 11. Stop-reagent - 1 bottle. (12.5 ml). Accessories: 1. Auxiliary plate for preliminary dilution of samples - 2 pcs. 2. Auxiliary plastic containers - 4 pcs. 3. Disposable tips for automatic pipettes - 16 pcs. 4. Adhesive film for tablets - 4 pcs. - Roszdravnadzor Registration РЗН 2017/5933

Access comprehensive regulatory information for Reagent kit "Enzyme immunoassay test system for the detection of class M immunoglobulins to respiratory syncytial virus" "ELISA-PCB-IgM" as per TU 9398-220-70423725-2016 Composed of: 1. Immunosorbent - 1 tablet. 2. Control positive sample (K+) - 1 vial. (1.2 ml). 3. Control sample of the level of "slice" (K + por) - 1 fl. (1.2 ml). 4. Control negative sample (K-) - 1 fl. (1.2 ml). 5. Conjugate - 1 fl. (13 ml). 6. Solution for diluting samples (PPO) - 1 bottle. (15 ml). 7. Solution for preliminary dilution of samples (RPRO) - 1 bottle. (15 ml). 8. Blocking solution (BR) - 1 bottle. (7.5 ml). 9. 25-fold concentrate of flushing solution (PR (x25)) - 2 fl. (40 ml each). 10. Indicator solution (RI) - 1 bottle. (13 ml). 11. Stop-reagent - 1 bottle. (12.5 ml). Accessories: 1. Auxiliary plate for preliminary dilution of samples - 2 pcs. 2. Auxiliary plastic containers - 4 pcs. 3. Disposable tips for automatic pipettes - 16 pcs. 4. Adhesive film for tablets - 4 pcs. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number РЗН 2017/5933 and manufactured by ECOlab JSC. The device was registered on September 25, 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.