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A set of reagents for the qualitative enzyme-linked immunosorbent assay of total IgG/IgM/IgA antibodies to the SARS-CoV-2 coronavirus in human serum and plasma SARS-CoV-2ELISA-total antibodies series E004 consisting of:I. A set of reagents consisting of:1. A set of twelve 8-hole strips in ... (see the full description in the card) - Roszdravnadzor Registration РЗН 2020/12364

Access comprehensive regulatory information for A set of reagents for the qualitative enzyme-linked immunosorbent assay of total IgG/IgM/IgA antibodies to the SARS-CoV-2 coronavirus in human serum and plasma SARS-CoV-2ELISA-total antibodies series E004 consisting of:I. A set of reagents consisting of:1. A set of twelve 8-hole strips in ... (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 2020/12364 and manufactured by Alkor Bio Company Ltd.. The device was registered on October 28, 2020.

This page provides complete registration details including device type, manufacturer information, country of origin (Russia), 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 2020/12364
A set of reagents for the qualitative enzyme-linked immunosorbent assay of total IgG/IgM/IgA antibodies to the SARS-CoV-2 coronavirus in human serum and plasma SARS-CoV-2ELISA-total antibodies series E004 consisting of:I. A set of reagents consisting of:1. A set of twelve 8-hole strips in ... (see the full description in the card)
Набор реагентов для качественного иммуноферментного определения суммарных антител IgG/IgM/IgA к коронавирусу SARS-CoV-2 в сыворотке и плазме крови человека SARS-CoV-2ИФА-суммарные антитела серия Е004 в составе:I. Набор реагентов в составе:1. Комплект из двенадцати 8-луночных стрипов в ... (см. в карточке полное описание)
Roszdravnadzor Registration Number: РЗН 2020/12364
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Device Information
Device Name (English)
A set of reagents for the qualitative enzyme-linked immunosorbent assay of total IgG/IgM/IgA antibodies to the SARS-CoV-2 coronavirus in human serum and plasma SARS-CoV-2ELISA-total antibodies series E004 consisting of:I. A set of reagents consisting of:1. A set of twelve 8-hole strips in ... (see the full description in the card)
Device Name (Russian)
Набор реагентов для качественного иммуноферментного определения суммарных антител IgG/IgM/IgA к коронавирусу SARS-CoV-2 в сыворотке и плазме крови человека SARS-CoV-2ИФА-суммарные антитела серия Е004 в составе:I. Набор реагентов в составе:1. Комплект из двенадцати 8-луночных стрипов в ... (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
47642
Registration Number
РЗН 2020/12364
Registration Date
October 28, 2020
Validity Period
January 01, 2025
Manufacturer Information
Manufacturer Name (English)
Alkor Bio Company Ltd.
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
192148 Russia, St. Petersburg, Zheleznodorozhny Ave. d. 40 lit. And of. 217
Legal Address (Russian)
192148 Россия г. Санкт-Петербург Железнодорожный пр-кт. д. 40 лит. А оф. 217
Manufacturing Address
ООО Компания Алкор Био Россия 192148 г. Санкт-Петербург Железнодорожный пр-кт. д. 40 лит. А