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Control materials for monitoring the characteristics of the system for analyzing the qualitative determination of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma by the immunochemiluminescent method for in vitro diagnostics on immunochemical analyzers of the ACCESS system series (ACCESS SARS-CoV-2 ... (see the full description in the card) - Roszdravnadzor Registration РЗН 2022/17294

Access comprehensive regulatory information for Control materials for monitoring the characteristics of the system for analyzing the qualitative determination of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma by the immunochemiluminescent method for in vitro diagnostics on immunochemical analyzers of the ACCESS system series (ACCESS SARS-CoV-2 ... (see the full description in the card) 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 2022/17294 and manufactured by Beckman Coulter Inc.. The device was registered on May 23, 2022.

This page provides complete registration details including device type, manufacturer information, country of origin (USA), 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 2b
РЗН 2022/17294
Control materials for monitoring the characteristics of the system for analyzing the qualitative determination of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma by the immunochemiluminescent method for in vitro diagnostics on immunochemical analyzers of the ACCESS system series (ACCESS SARS-CoV-2 ... (see the full description in the card)
Контрольные материалы для контроля характеристик системы анализа качественного определения антител класса IgG к вирусу SARS-CoV-2 в сыворотке и плазме крови человека иммунохемилюминесцентным методом для диагностики in vitro на анализаторах иммунохимических серии ACCESS system (ACCESS SARS-CoV-2 ... (см. в карточке полное описание)
Roszdravnadzor Registration Number: РЗН 2022/17294
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Device Information
Device Name (English)
Control materials for monitoring the characteristics of the system for analyzing the qualitative determination of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma by the immunochemiluminescent method for in vitro diagnostics on immunochemical analyzers of the ACCESS system series (ACCESS SARS-CoV-2 ... (see the full description in the card)
Device Name (Russian)
Контрольные материалы для контроля характеристик системы анализа качественного определения антител класса IgG к вирусу SARS-CoV-2 в сыворотке и плазме крови человека иммунохемилюминесцентным методом для диагностики in vitro на анализаторах иммунохимических серии ACCESS system (ACCESS SARS-CoV-2 ... (см. в карточке полное описание)
Device Type (English)
N/A
Device Type (Russian)
Unknown
Risk Class
Class 2b
OKPD Code
21.20.23.110
Registration Information
Registry Key
63887
Registration Number
РЗН 2022/17294
Registration Date
May 23, 2022
Validity Period
January 01, 2025
Manufacturer Information
Manufacturer Name (English)
Beckman Coulter Inc.
Manufacturer Name (Russian)
Бекмен Культер Инк.
Country (English)
USA
Country (Russian)
USA
Legal Address (English)
США Дальнее зарубежье Beckman Coulter Inc. 250 South Kraemer Blvd. Brea CA 92821 USA
Legal Address (Russian)
США Дальнее зарубежье Beckman Coulter Inc. 250 South Kraemer Blvd. Brea CA 92821 USA
Manufacturing Address
1. Beckman Coulter Inc. 1000 Lake Hazeltine Drive Chaska MN 55318 USA.2. Immunotech SAS A Beckman Coulter Company 130 Avenue de Lattre de Tassigny BP 177 Marseille Cedex 9 13276 France.