A set of reagents for the qualitative enzyme immunoassay determination of immunoglobulins M to the SARS-CoV-2 coronavirus in human serum and plasma SARS-CoV-2ELISA-IgM series E003 consisting of:I. Reagent kit:1. A set of twelve 8-hole strips in a frame with immobilized on the internal... (see the full description in the card)
Russia·Unknown·Alkor Bio Company Ltd.·Registered September 11, 2020·Class 2b- Device Name (English)
- A set of reagents for the qualitative enzyme immunoassay determination of immunoglobulins M to the SARS-CoV-2 coronavirus in human serum and plasma SARS-CoV-2ELISA-IgM series E003 consisting of:I. Reagent kit:1. A set of twelve 8-hole strips in a frame with immobilized on the internal... (see the full description in the card)
- Device Name (Russian)
- Набор реагентов для качественного иммуноферментного определения иммуноглобулинов M к коронавирусу SARS-CoV-2 в сыворотке и плазме крови человека SARS-CoV-2ИФА-IgM серия Е003 в составе:I. Набор реагентов:1. Комплект из двенадцати 8-луночных стрипов в рамке с иммобилизованными на внутренн... (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
- 47180
- Registration Number
- РЗН 2020/11933
- Registration Date
- September 11, 2020
- Validity Period
- January 01, 2025
- Manufacturer Name (English)
- Alkor Bio Company Ltd.
- Manufacturer Name (Russian)
- ООО Компания Алкор Био
- 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
Access comprehensive regulatory information for A set of reagents for the qualitative enzyme immunoassay determination of immunoglobulins M to the SARS-CoV-2 coronavirus in human serum and plasma SARS-CoV-2ELISA-IgM series E003 consisting of:I. Reagent kit:1. A set of twelve 8-hole strips in a frame with immobilized on the internal... (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 2020/11933 and manufactured by Alkor Bio Company Ltd.. The device was registered on September 11, 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.