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Set of reagents Enzyme immunoassay system for qualitative and semi-quantitative determination of class G antibodies to SARS-CoV-2 SARS-CoV-2-IgG ELISA series 03 series 04 according to TU 21.20.23-299-70423725-2020 consisting of: 1. Immunosorbent -1 tablet 2. Control positive sample (K +) - 1 ... (see the full description in the card) - Roszdravnadzor Registration РЗН 2020/11489

Access comprehensive regulatory information for Set of reagents Enzyme immunoassay system for qualitative and semi-quantitative determination of class G antibodies to SARS-CoV-2 SARS-CoV-2-IgG ELISA series 03 series 04 according to TU 21.20.23-299-70423725-2020 consisting of: 1. Immunosorbent -1 tablet 2. Control positive sample (K +) - 1 ... (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 2020/11489 and manufactured by CJSC EKOlab. The device was registered on July 24, 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 2020/11489
Set of reagents Enzyme immunoassay system for qualitative and semi-quantitative determination of class G antibodies to SARS-CoV-2 SARS-CoV-2-IgG ELISA series 03 series 04 according to TU 21.20.23-299-70423725-2020 consisting of: 1. Immunosorbent -1 tablet 2. Control positive sample (K +) - 1 ... (see the full description in the card)
Набор реагентов Тест-система иммуноферментная для качественного и полуколичественного определения антител класса G к SARS-CoV-2 SARS-CoV-2-IgG ИФА серия 03 серия 04 по ТУ 21.20.23-299-70423725-2020 в составе: 1. Иммуносорбент -1 планшет2. Контрольный положительный образец (К+) - 1 ... (см. в карточке полное описание)
Roszdravnadzor Registration Number: РЗН 2020/11489
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Device Information
Device Name (English)
Set of reagents Enzyme immunoassay system for qualitative and semi-quantitative determination of class G antibodies to SARS-CoV-2 SARS-CoV-2-IgG ELISA series 03 series 04 according to TU 21.20.23-299-70423725-2020 consisting of: 1. Immunosorbent -1 tablet 2. Control positive sample (K +) - 1 ... (see the full description in the card)
Device Name (Russian)
Набор реагентов Тест-система иммуноферментная для качественного и полуколичественного определения антител класса G к SARS-CoV-2 SARS-CoV-2-IgG ИФА серия 03 серия 04 по ТУ 21.20.23-299-70423725-2020 в составе: 1. Иммуносорбент -1 планшет2. Контрольный положительный образец (К+) - 1 ... (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
45748
Registration Number
РЗН 2020/11489
Registration Date
July 24, 2020
Validity Period
January 01, 2025
Manufacturer Information
Manufacturer Name (English)
CJSC EKOlab
Manufacturer Name (Russian)
ЗАО ЭКОлаб
Country (English)
Russia
Country (Russian)
Россия
Legal Address (English)
142530, Moscow, region, Elektrogorsk, Budyonny str., 1
Legal Address (Russian)
142530 Россия Московская область г. Электрогорск ул. Буденного д. 1
Manufacturing Address
1. ЗАО ЭКОлаб Россия 142530 Московская область г. Электрогорск ул. Буденного д. 1а.2. Закрытое акционерное общество ЭКОлаб Россия 142530 Московская область г. Электрогорск ул. Буденного д. 1.