A set of reagents and calibrators for the qualitative determination of total IgM/IgG antibodies to SARS-CoV-2 by immunochemiluminescent method in serum and blood plasma using analyzers and modules of immunochemical cobas e (Elecsys Anti-SARS-Cov-2 cobas e analyzers/ACOV2) 200 tests series 49930001 consisting of:... (see the full description in the card)
Russia·Unknown·Roche Diagnostics GmbH·Registered August 18, 2020·Class 3- Device Name (English)
- A set of reagents and calibrators for the qualitative determination of total IgM/IgG antibodies to SARS-CoV-2 by immunochemiluminescent method in serum and blood plasma using analyzers and modules of immunochemical cobas e (Elecsys Anti-SARS-Cov-2 cobas e analyzers/ACOV2) 200 tests series 49930001 consisting of:... (see the full description in the card)
- Device Name (Russian)
- Набор реагентов и калибраторов для качественного определения общих антител IgM/IgG к SARS-CoV-2 иммунохемилюминесцентным методом в сыворотке и плазме крови на анализаторах и модулях иммунохимических cobas e (Elecsys Anti-SARS-Cov-2 cobas e analyzers/ACOV2) 200 тестов серия 49930001 в составе:... (см. в карточке полное описание)
- Device Type (English)
- N/A
- Device Type (Russian)
- Unknown
- Risk Class
- Class 3
- OKPD Code
- 21.20.23.110
- Registry Key
- 46047
- Registration Number
- РЗН 2020/11754
- Registration Date
- August 18, 2020
- Validity Period
- January 01, 2021
- Manufacturer Name (English)
- Roche Diagnostics GmbH
- Manufacturer Name (Russian)
- Рош Диагностикс ГмбХ
- Country (English)
- Germany
- Country (Russian)
- Germany
- Legal Address (English)
- Германия Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany
- Legal Address (Russian)
- Германия Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany
- Manufacturing Address
- 1. Roche Diagnostics GmbH Centralised and Point of Care Solutions Sandhofer Strasse 116 68305 Mannheim Germany.2. Roche Diagnostics GmbH Centralised and Point of Care Solutions Nonnenwald 2 82377 Penzberg Germany.
Access comprehensive regulatory information for A set of reagents and calibrators for the qualitative determination of total IgM/IgG antibodies to SARS-CoV-2 by immunochemiluminescent method in serum and blood plasma using analyzers and modules of immunochemical cobas e (Elecsys Anti-SARS-Cov-2 cobas e analyzers/ACOV2) 200 tests series 49930001 consisting of:... (see the full description in the card) in the Russia medical device market through Pure Global AI's free database. This Class 3 medical device is registered under Roszdravnadzor registration number РЗН 2020/11754 and manufactured by Roche Diagnostics GmbH. The device was registered on August 18, 2020.
This page provides complete registration details including device type, manufacturer information, country of origin (Germany), 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.