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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) - Roszdravnadzor Registration РЗН 2020/11685

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.

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Class 2b
РЗН 2020/11685
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)
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)
Roszdravnadzor Registration Number: РЗН 2020/11685
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Device Information
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
Registration Information
Registry Key
45933
Registration Number
РЗН 2020/11685
Registration Date
August 12, 2020
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 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