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)
Russia·Unknown·Beckman Coulter Inc.·Registered August 11, 2020·Class 2b- 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
- Registry Key
- 45935
- Registration Number
- РЗН 2020/11689
- Registration Date
- August 11, 2020
- Validity Period
- January 01, 2021
- 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
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.