"Reagent kit for the quantitative determination of class M antibodies to cardiolipin by enzyme-linked immunosorbent assay" ("DS-ELISA-ANTI-CARDIOLIPIN-M") according to TU 21.20.23-250-05941003-2022 - Immunosorbent - 96-well collapsible polystyrene plate (up to the wells), in the wells of which cardiolipin with purified β2-glycoprotein 1 used as a co-factor is sorbed, ready for use: 1 plate; - Human IgM antibody conjugate, labeled with horseradish peroxidase, ready for use: 1 vial. 12.0 ml; - K+ - control positive sample, ready for use: 1 fl. 1.2 ml; - K- - control negative sample, ready for use: 1 fl. 2.5 ml; - Calibrators - calibrators containing known amounts of class M antibodies to cardiolipin are ready for use: Calibrator 0 - 1 fl. 1.0 ml, Calibrator 1 - 1 fl. 1.0 ml, Calibrator 2 ? 1 fl. 1.0 ml, Calibrator 3 ? 1 fl. 1.0 ml, Calibrator 4 - 1 vial. 1.0 ml, Calibrator 5 ? 1 fl. 1.0 ml; - BR - block solution for diluting serums, ready for use: 1 bottle. 12.5 ml; - PPC - solution for preliminary dilution of serums, ready for use: 1 bottle. 12.5 ml; - PR - flushing solution, concentrate (×25) of phosphate-saline buffer solution with twin (FSB-T): 1 fl. 50.0 ml; - Stop-reagent - sulfuric acid solution (0.2M), ready for use: 1 vial. 25.0 ml; - TMB-Substrate solution, ready to use: 1 fl. 14.0 ml; - tablet for pre-dilution of serums: 1 tablet; - protective film for ELISA tablets: 2 pcs.; - disposable tips: 16 pcs.; - plastic bath for liquid reagents: 2 pcs.; - plastic bag with Zip-Lock: 1 pc.; - Form for building a calibration graph: 1 pc.; - Instructions for use: 1 pc. - Roszdravnadzor Registration РЗН 2023/19431

Access comprehensive regulatory information for "Reagent kit for the quantitative determination of class M antibodies to cardiolipin by enzyme-linked immunosorbent assay" ("DS-ELISA-ANTI-CARDIOLIPIN-M") according to TU 21.20.23-250-05941003-2022 - Immunosorbent - 96-well collapsible polystyrene plate (up to the wells), in the wells of which cardiolipin with purified β2-glycoprotein 1 used as a co-factor is sorbed, ready for use: 1 plate; - Human IgM antibody conjugate, labeled with horseradish peroxidase, ready for use: 1 vial. 12.0 ml; - K+ - control positive sample, ready for use: 1 fl. 1.2 ml; - K- - control negative sample, ready for use: 1 fl. 2.5 ml; - Calibrators - calibrators containing known amounts of class M antibodies to cardiolipin are ready for use: Calibrator 0 - 1 fl. 1.0 ml, Calibrator 1 - 1 fl. 1.0 ml, Calibrator 2 ? 1 fl. 1.0 ml, Calibrator 3 ? 1 fl. 1.0 ml, Calibrator 4 - 1 vial. 1.0 ml, Calibrator 5 ? 1 fl. 1.0 ml; - BR - block solution for diluting serums, ready for use: 1 bottle. 12.5 ml; - PPC - solution for preliminary dilution of serums, ready for use: 1 bottle. 12.5 ml; - PR - flushing solution, concentrate (×25) of phosphate-saline buffer solution with twin (FSB-T): 1 fl. 50.0 ml; - Stop-reagent - sulfuric acid solution (0.2M), ready for use: 1 vial. 25.0 ml; - TMB-Substrate solution, ready to use: 1 fl. 14.0 ml; - tablet for pre-dilution of serums: 1 tablet; - protective film for ELISA tablets: 2 pcs.; - disposable tips: 16 pcs.; - plastic bath for liquid reagents: 2 pcs.; - plastic bag with Zip-Lock: 1 pc.; - Form for building a calibration graph: 1 pc.; - Instructions for use: 1 pc. 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 2023/19431 and manufactured by LLC "NPO "Diagnostic Systems". The device was registered on January 27, 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.