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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 LOT tests 51233901 consisting of:... (see the full description in the card) - Roszdravnadzor Registration РЗН 2020/12412

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 LOT tests 51233901 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 2020/12412 and manufactured by Roche Diagnostics GmbH. The device was registered on October 30, 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.

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Class 3
РЗН 2020/12412
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 LOT tests 51233901 consisting of:... (see the full description in the card)
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 LOT 51233901 в составе:... (см. в карточке полное описание)
Roszdravnadzor Registration Number: РЗН 2020/12412
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Device Information
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 LOT tests 51233901 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 LOT 51233901 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
Registration Information
Registry Key
48374
Registration Number
РЗН 2020/12412
Registration Date
October 30, 2020
Validity Period
January 01, 2021
Manufacturer Information
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 D-68305 Mannheim Germany
Legal Address (Russian)
Германия Roche Diagnostics GmbH Sandhofer Strasse 116 D-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.