Reagent for the qualitative determination of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma by immunochemiluminescent method for in vitro diagnostics on immunochemical analyzers of the ACCESS system series lot 971197 Reagent for the qualitative determination of IgG antibodies to... (see the full description in the card)
Russia·Unknown·Beckman Coulter Inc.·Registered August 12, 2020·Class 2b- Device Name (English)
- Reagent for the qualitative determination of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma by immunochemiluminescent method for in vitro diagnostics on immunochemical analyzers of the ACCESS system series lot 971197 Reagent for the qualitative determination of IgG antibodies to... (see the full description in the card)
- Device Name (Russian)
- Реагент для 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 971197 Реагент для качественного определения антител класса IgG к... (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
- 45933
- Registration Number
- РЗН 2020/11685
- Registration Date
- August 12, 2020
- 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 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
- Beckman Coulter Ireland Inc. Lismeehan O'Callaghan's Mills Co. Clare Ireland
Access comprehensive regulatory information for Reagent for the qualitative determination of IgG antibodies to the SARS-CoV-2 virus in human serum and plasma by immunochemiluminescent method for in vitro diagnostics on immunochemical analyzers of the ACCESS system series lot 971197 Reagent for the qualitative determination of IgG antibodies to... (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 2020/11685 and manufactured by Beckman Coulter Inc.. The device was registered on August 12, 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.