Pure Global

Reagent kit for the analysis of human serum or blood plasma for the presence of specific class G immunoglobulins to the SARS-CoV-2 virus nucleocapsid by enzyme-linked immunosorbent assay (ELISA anti-SARS-CoV-2 IgG reagent kit as per TU 21.20.23-356-78095326-2021, Series 07 1. SARS-CoV-2 IgG Tablet - 2 pcs. 2. K+ SARS-CoV-2 IgG, 4.0 ml - 1 vial. 3. K-SARS-CoV-2 IgG, 4.0 ml - 1 vial. 4. 200x anti-IgG conjugate concentrate, 0.3ml - 1 vial. 5. 10-x solution for dilution and washing, 40.0 ml - 3 vials. 6. TMB, 14.0 ml - 2 vials. 7. Stop reagent, 10.0 ml - 1 vial. 8. Instructions for use - 1 pc. 9. Quality passport - 1 pc. - Roszdravnadzor Registration РЗН 2022/16468

Access comprehensive regulatory information for Reagent kit for the analysis of human serum or blood plasma for the presence of specific class G immunoglobulins to the SARS-CoV-2 virus nucleocapsid by enzyme-linked immunosorbent assay (ELISA anti-SARS-CoV-2 IgG reagent kit as per TU 21.20.23-356-78095326-2021, Series 07 1. SARS-CoV-2 IgG Tablet - 2 pcs. 2. K+ SARS-CoV-2 IgG, 4.0 ml - 1 vial. 3. K-SARS-CoV-2 IgG, 4.0 ml - 1 vial. 4. 200x anti-IgG conjugate concentrate, 0.3ml - 1 vial. 5. 10-x solution for dilution and washing, 40.0 ml - 3 vials. 6. TMB, 14.0 ml - 2 vials. 7. Stop reagent, 10.0 ml - 1 vial. 8. Instructions for use - 1 pc. 9. Quality 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 2022/16468 and manufactured by State Research Center for Applied Microbiology and Biotechnology of the Federal Service for Surveillance on Consumer Rights Protection and Human Welfare. The device was registered on February 01, 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.

Free Database
Powered by Pure Global AI
Roszdravnadzor Official Data
Class 2b
РЗН 2022/16468
Reagent kit for the analysis of human serum or blood plasma for the presence of specific class G immunoglobulins to the SARS-CoV-2 virus nucleocapsid by enzyme-linked immunosorbent assay (ELISA anti-SARS-CoV-2 IgG reagent kit as per TU 21.20.23-356-78095326-2021, Series 07 1. SARS-CoV-2 IgG Tablet - 2 pcs. 2. K+ SARS-CoV-2 IgG, 4.0 ml - 1 vial. 3. K-SARS-CoV-2 IgG, 4.0 ml - 1 vial. 4. 200x anti-IgG conjugate concentrate, 0.3ml - 1 vial. 5. 10-x solution for dilution and washing, 40.0 ml - 3 vials. 6. TMB, 14.0 ml - 2 vials. 7. Stop reagent, 10.0 ml - 1 vial. 8. Instructions for use - 1 pc. 9. Quality passport - 1 pc.
Набор реагентов для анализа сыворотки или плазмы крови человека на наличие специфических иммуноглобулинов класса G к нуклеокапсиду вируса SARS-CoV-2 методом иммуноферментного анализа (Набор реагентов «ИФА анти-SARS-CoV-2 IgG» по ТУ 21.20.23-356-78095326-2021, Серия 07 1. Планшет SARS-CoV-2 IgG - 2 шт. 2. К+ SARS-CoV-2 IgG, 4,0 мл - 1 флакон. 3. К- SARS-CoV-2 IgG, 4,0 мл - 1 флакон. 4. 200х Концентрат конъюгата anti-IgG, 0,3мл - 1 флакон. 5. 10-х Раствор для разведения и отмывки, 40,0 мл - 3 флакона. 6. ТМБ, 14,0 мл - 2 флакона. 7. Стоп-реагент, 10,0 мл - 1 флакон. 8. Инструкция по применению - 1 шт. 9. Паспорт качества - 1 шт.
Roszdravnadzor Registration Number: РЗН 2022/16468
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Information
Device Name (English)
Reagent kit for the analysis of human serum or blood plasma for the presence of specific class G immunoglobulins to the SARS-CoV-2 virus nucleocapsid by enzyme-linked immunosorbent assay (ELISA anti-SARS-CoV-2 IgG reagent kit as per TU 21.20.23-356-78095326-2021, Series 07 1. SARS-CoV-2 IgG Tablet - 2 pcs. 2. K+ SARS-CoV-2 IgG, 4.0 ml - 1 vial. 3. K-SARS-CoV-2 IgG, 4.0 ml - 1 vial. 4. 200x anti-IgG conjugate concentrate, 0.3ml - 1 vial. 5. 10-x solution for dilution and washing, 40.0 ml - 3 vials. 6. TMB, 14.0 ml - 2 vials. 7. Stop reagent, 10.0 ml - 1 vial. 8. Instructions for use - 1 pc. 9. Quality passport - 1 pc.
Device Name (Russian)
Набор реагентов для анализа сыворотки или плазмы крови человека на наличие специфических иммуноглобулинов класса G к нуклеокапсиду вируса SARS-CoV-2 методом иммуноферментного анализа (Набор реагентов «ИФА анти-SARS-CoV-2 IgG» по ТУ 21.20.23-356-78095326-2021, Серия 07 1. Планшет SARS-CoV-2 IgG - 2 шт. 2. К+ SARS-CoV-2 IgG, 4,0 мл - 1 флакон. 3. К- SARS-CoV-2 IgG, 4,0 мл - 1 флакон. 4. 200х Концентрат конъюгата anti-IgG, 0,3мл - 1 флакон. 5. 10-х Раствор для разведения и отмывки, 40,0 мл - 3 флакона. 6. ТМБ, 14,0 мл - 2 флакона. 7. Стоп-реагент, 10,0 мл - 1 флакон. 8. Инструкция по применению - 1 шт. 9. Паспорт качества - 1 шт.
Device Type (English)
N/A
Device Type (Russian)
142260
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
60702.0
Registration Number
РЗН 2022/16468
Registration Date
February 01, 2022
Validity Period
January 01, 2025
Manufacturer Information
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
FBI SSC PMB, Russia, 142279, Moscow region, Serpukhov, Obolensk, ter. "Kvartal A", 10
Legal Address (Russian)
ФБУН ГНЦ ПМБ, Россия, 142279, Московская область, г.о. Серпухов, п. Оболенск, тер. "Квартал А", д. 10
Manufacturing Address
142279, Россия, Московская область, городской округ Серпухов, п. Оболенск, территория "Квартал А", д. 24