Reagent kit "Enzyme immunoassay test system for the qualitative detection of class M antibodies to SARS-CoV-2" "ELISA-SARS-CoV-2-Anti-M" TU 21.20.23-316-70423725-2021 Set No1: Immunosorbent - 1 plate (12 strips), control positive sample (K'*') - 1 fl. (2.0 ml), control negative sample (K?) - 1 fl. (3.0 ml), Conjugate - 1 fl. (14 ml), solution for preliminary dilution of samples (RPRO) - 1 bottle. (14 ml), Sample dilution solution (PPO) - 1 bottle. (14 ml), 25-fold concentrate of phosphate-saline buffer solution with twin (FSB-T (x25)) 1 fl. (50 ml), indicator solution (RI) - 1 fl. (14 ml), stop reagent - 1 vial. (14 ml), collapsible plate for preliminary dilution of the studied samples - 1 pc. Disposable tips for automatic pipettes (2-200 μl) - 16 pcs. auxiliary plastic containers -4 pcs. Adhesive film for tablets -4 pcs. Set No2: immunosorbent - 5 plates (60 strips), control positive sample (K"^) - 3 fl. (4 ml each) control negative sample (K?) - 3 fl. (4 ml each) Conjugate - 5 vials. (14 ml each) solution for preliminary dilution of samples (RPRO) - 1 bottle. (70 ml), Sample dilution solution (PPO) - 5 bottles. (14 ml each) 25-fold concentrate of phosphate-salt buffer solution with twin (FSB-T (x25)) - 2 bottles. (100 ml), indicator solution (RI) - 5 vials. (14 ml each), stop reagent - 3 vials. (25 ml each), collapsible plate for preliminary dilution of the studied samples - 5 pcs. Disposable tips for automatic pipettes (2-200 μL) - 32 pcs. auxiliary plastic containers - 8 pcs. Adhesive film for tablets - 8 pcs. - Roszdravnadzor Registration РЗН 2022/18809

Access comprehensive regulatory information for Reagent kit "Enzyme immunoassay test system for the qualitative detection of class M antibodies to SARS-CoV-2" "ELISA-SARS-CoV-2-Anti-M" TU 21.20.23-316-70423725-2021 Set No1: Immunosorbent - 1 plate (12 strips), control positive sample (K'*') - 1 fl. (2.0 ml), control negative sample (K?) - 1 fl. (3.0 ml), Conjugate - 1 fl. (14 ml), solution for preliminary dilution of samples (RPRO) - 1 bottle. (14 ml), Sample dilution solution (PPO) - 1 bottle. (14 ml), 25-fold concentrate of phosphate-saline buffer solution with twin (FSB-T (x25)) 1 fl. (50 ml), indicator solution (RI) - 1 fl. (14 ml), stop reagent - 1 vial. (14 ml), collapsible plate for preliminary dilution of the studied samples - 1 pc. Disposable tips for automatic pipettes (2-200 μl) - 16 pcs. auxiliary plastic containers -4 pcs. Adhesive film for tablets -4 pcs. Set No2: immunosorbent - 5 plates (60 strips), control positive sample (K"^) - 3 fl. (4 ml each) control negative sample (K?) - 3 fl. (4 ml each) Conjugate - 5 vials. (14 ml each) solution for preliminary dilution of samples (RPRO) - 1 bottle. (70 ml), Sample dilution solution (PPO) - 5 bottles. (14 ml each) 25-fold concentrate of phosphate-salt buffer solution with twin (FSB-T (x25)) - 2 bottles. (100 ml), indicator solution (RI) - 5 vials. (14 ml each), stop reagent - 3 vials. (25 ml each), collapsible plate for preliminary dilution of the studied samples - 5 pcs. Disposable tips for automatic pipettes (2-200 μL) - 32 pcs. auxiliary plastic containers - 8 pcs. Adhesive film for tablets - 8 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 2022/18809 and manufactured by CJSC "ECOlab". The device was registered on November 17, 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.