Reagent kit for quantitative enzyme-linked immunoglobulins of class G (IgG) to the SARS-CoV-2 virus (COVID-19) in human serum (plasma) "Quantitative IgG-SARS-CoV-2-Imaxiz (IMAXYZ)" according to TU 21.20.23-114-94568735-2021 Set 1: - microplate - 1 package; - Conjugate - 1 vial (14 ml); - calibration samples - 6 vials (1.0 ml each); - control serum - 1 vial (1.0 ml); - Buffer P - 1 vial (24 ml); - Buffer A - 1 vial (14 ml); - TMB solution - 1 vial (14 ml); - Stop reagent - I vial (14 ml); - Buffer P - 1 vial (50 ml); - resealable bag - 1 pc.; - film for gluing a microplate - 2 pcs.; - baths for applying reagents - 2 pcs.; '' - disposable tips for dispensers - 16 pcs; - collapsible polystyrene plate for preliminary dilution of the studied samples - 2 pcs. Set 2: - microplate - 5 packages; - conjugate - 5 vials (14 ml each); - calibration samples ? 5 sets of 6 vials (1.0 ml each); - control serum - 5 vials (1.0 ml each); - Buffer P - 5 vials (24 ml each); - Buffer A - 5 vials (14 ml each); - TMB solution - 5 vials (14 ml each); - stop reagent - 5 vials (14 ml each); - Buffer P - 5 vials (50 ml each); - resealable bag - 5 pcs.; - film for gluing a microplate - 10 pcs.; - Baths for applying reagents - 10 pcs.; - disposable tips for dispensers - 80 pcs; - collapsible polystyrene plate for preliminary dilution of the studied samples - 10 pcs. - Roszdravnadzor Registration РЗН 2022/17727

Access comprehensive regulatory information for Reagent kit for quantitative enzyme-linked immunoglobulins of class G (IgG) to the SARS-CoV-2 virus (COVID-19) in human serum (plasma) "Quantitative IgG-SARS-CoV-2-Imaxiz (IMAXYZ)" according to TU 21.20.23-114-94568735-2021 Set 1: - microplate - 1 package; - Conjugate - 1 vial (14 ml); - calibration samples - 6 vials (1.0 ml each); - control serum - 1 vial (1.0 ml); - Buffer P - 1 vial (24 ml); - Buffer A - 1 vial (14 ml); - TMB solution - 1 vial (14 ml); - Stop reagent - I vial (14 ml); - Buffer P - 1 vial (50 ml); - resealable bag - 1 pc.; - film for gluing a microplate - 2 pcs.; - baths for applying reagents - 2 pcs.; '' - disposable tips for dispensers - 16 pcs; - collapsible polystyrene plate for preliminary dilution of the studied samples - 2 pcs. Set 2: - microplate - 5 packages; - conjugate - 5 vials (14 ml each); - calibration samples ? 5 sets of 6 vials (1.0 ml each); - control serum - 5 vials (1.0 ml each); - Buffer P - 5 vials (24 ml each); - Buffer A - 5 vials (14 ml each); - TMB solution - 5 vials (14 ml each); - stop reagent - 5 vials (14 ml each); - Buffer P - 5 vials (50 ml each); - resealable bag - 5 pcs.; - film for gluing a microplate - 10 pcs.; - Baths for applying reagents - 10 pcs.; - disposable tips for dispensers - 80 pcs; - collapsible polystyrene plate for preliminary dilution of the studied samples - 10 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 2022/17727 and manufactured by Vital Development Corporation JSC. The device was registered on July 12, 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.