HSV 1,2 IgM-ELISA reagent kit for enzyme-linked immunosorbent detection of IgM antibodies to Herpes simplex virus type 1 and 2 (HSV1, 2) in blood serum (plasma) , consisting of: - tablet - 1 pc.; - negative control - 1 x 0.5 ml; - positive control - 1 x 0.2 ml; - conjugate concentrate - 1 x 1.25 ml; - Conjugate concentrate dilution buffer - 1 x 12 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 2024/22161

Access comprehensive regulatory information for HSV 1,2 IgM-ELISA reagent kit for enzyme-linked immunosorbent detection of IgM antibodies to Herpes simplex virus type 1 and 2 (HSV1, 2) in blood serum (plasma) , consisting of: - tablet - 1 pc.; - negative control - 1 x 0.5 ml; - positive control - 1 x 0.2 ml; - conjugate concentrate - 1 x 1.25 ml; - Conjugate concentrate dilution buffer - 1 x 12 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 2024/22161 and manufactured by HEMA LLC. The device was registered on March 04, 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.