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)
Russia·Unknown·Beckman Coulter Inc.·Registered May 23, 2022·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 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
- Registry Key
- 63887
- Registration Number
- РЗН 2022/17294
- Registration Date
- May 23, 2022
- Validity Period
- January 01, 2025
- 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.
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.