Reagent kit Rapid test for the detection of SARS-CoV-2 antigen by membrane-immunochromatographic analysis (COVID-19 Ag rapid test) according to TU 21.20.23-340-78095326-2021, series 01 Composed of: 1. Express test in individual packaging, plastic panel - 20 pcs. 2. Universal probe type A3 in individual packaging, sterile, manufactured by Medical Devices LLC, RU No RZN 2018/7058 - 20 pcs. 3. Disposable pipette - 20 pcs. 4. Extraction solution - screw tube, 0.35 ml - 20 pcs. 5. Instructions for use - 1 pc. - Roszdravnadzor Registration РЗН 2021/13393

Access comprehensive regulatory information for Reagent kit Rapid test for the detection of SARS-CoV-2 antigen by membrane-immunochromatographic analysis (COVID-19 Ag rapid test) according to TU 21.20.23-340-78095326-2021, series 01 Composed of: 1. Express test in individual packaging, plastic panel - 20 pcs. 2. Universal probe type A3 in individual packaging, sterile, manufactured by Medical Devices LLC, RU No RZN 2018/7058 - 20 pcs. 3. Disposable pipette - 20 pcs. 4. Extraction solution - screw tube, 0.35 ml - 20 pcs. 5. Instructions for use - 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 2021/13393 and manufactured by BU SSC PMB. The device was registered on February 02, 2021.

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.