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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 lot 988605 ... (see the full description in the card) - Roszdravnadzor Registration РЗН 2020/11689

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 lot 988605 ... (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 2020/11689 and manufactured by Beckman Coulter Inc.. The device was registered on August 11, 2020.

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 2020/11689
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 lot 988605 ... (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 лот 988605 Конт... (см. в карточке полное описание)
Roszdravnadzor Registration Number: РЗН 2020/11689
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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 lot 988605 ... (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 лот 988605 Конт... (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
45935
Registration Number
РЗН 2020/11689
Registration Date
August 11, 2020
Validity Period
January 01, 2021
Manufacturer Information
Manufacturer Name (English)
Beckman Coulter Inc.
Manufacturer Name (Russian)
Бекмен Культер Инк.
Country (English)
USA
Country (Russian)
USA
Legal Address (English)
США Beckman Coulter Inc. 250 S. Kraemer Blvd. Brea CA 92821 USA
Legal Address (Russian)
США Beckman Coulter Inc. 250 S. Kraemer Blvd. Brea CA 92821 USA
Manufacturing Address
Immunotech S.A.S. a Beckman Coulter Company 130 Avenue de Lattre de Tassigny BP 177 13276 Marseille Cedex 9 France