Reagent kit for enzyme-linked immunosorbent detection of IgM antibodies to Rubella antigens in blood serum (plasma) "Rubella IgM-ELISA" , consisting of: - tablet - 1 pc.; - negative control - 1 x 0.5 ml; - positive control - 1 x 0.2 ml; - conjugate - 1 x 14 ml; - ELISA-Buffer - 1 x 14 ml; - Tetramethylbenzidine substrate solution (TMB) - 1 x 14 ml; - washing solution concentrate - 1 x 22 ml; - stop reagent - 1 x 14 ml; - paper for gluing a tablet - 2 pcs.; - instructions for use - 1 pc.; - Quality control passport (analytical passport) - 1 pc. - Roszdravnadzor Registration РЗН 2024/22061

Access comprehensive regulatory information for Reagent kit for enzyme-linked immunosorbent detection of IgM antibodies to Rubella antigens in blood serum (plasma) "Rubella IgM-ELISA" , consisting of: - tablet - 1 pc.; - negative control - 1 x 0.5 ml; - positive control - 1 x 0.2 ml; - conjugate - 1 x 14 ml; - ELISA-Buffer - 1 x 14 ml; - Tetramethylbenzidine substrate solution (TMB) - 1 x 14 ml; - washing solution concentrate - 1 x 22 ml; - stop reagent - 1 x 14 ml; - paper for gluing a tablet - 2 pcs.; - instructions for use - 1 pc.; - Quality control passport (analytical passport) - 1 pc. 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 2024/22061 and manufactured by HEMA LLC. The device was registered on February 19, 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.