Pure Global

Set of reagents Enzyme immunoassay system for the qualitative determination of class M antibodies to SARS-CoV-2 SARS-CoV-2-IgM ELISA according to TU 21.20.23-301-70423725-2020 series: 03 04 I. Composition: 1. Immunosorbent - 1 tablet.2. Control positive sample (K +) - 1 fl. (03 ml).3. (see the full description in the card) - Roszdravnadzor Registration РЗН 2020/11658

Access comprehensive regulatory information for Set of reagents Enzyme immunoassay system for the qualitative determination of class M antibodies to SARS-CoV-2 SARS-CoV-2-IgM ELISA according to TU 21.20.23-301-70423725-2020 series: 03 04 I. Composition: 1. Immunosorbent - 1 tablet.2. Control positive sample (K +) - 1 fl. (03 ml).3. (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 2020/11658 and manufactured by CJSC EKOlab. The device was registered on August 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.

Free Database
Powered by Pure Global AI
Roszdravnadzor Official Data
Class 2b
РЗН 2020/11658
Set of reagents Enzyme immunoassay system for the qualitative determination of class M antibodies to SARS-CoV-2 SARS-CoV-2-IgM ELISA according to TU 21.20.23-301-70423725-2020 series: 03 04 I. Composition: 1. Immunosorbent - 1 tablet.2. Control positive sample (K +) - 1 fl. (03 ml).3. (see the full description in the card)
Набор реагентов Тест-система иммуноферментная для качественного определения антител класса М к SARS-CoV-2 SARS-CoV-2-IgМ ИФА по ТУ 21.20.23-301-70423725-2020 серии: 03 04 I.Состав: 1.Иммуносорбент - 1 планшет.2.Контрольный положительный образец (К+) - 1 фл. (03 мл).3.Контрольн... (см. в карточке полное описание)
Roszdravnadzor Registration Number: РЗН 2020/11658
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Information
Device Name (English)
Set of reagents Enzyme immunoassay system for the qualitative determination of class M antibodies to SARS-CoV-2 SARS-CoV-2-IgM ELISA according to TU 21.20.23-301-70423725-2020 series: 03 04 I. Composition: 1. Immunosorbent - 1 tablet.2. Control positive sample (K +) - 1 fl. (03 ml).3. (see the full description in the card)
Device Name (Russian)
Набор реагентов Тест-система иммуноферментная для качественного определения антител класса М к SARS-CoV-2 SARS-CoV-2-IgМ ИФА по ТУ 21.20.23-301-70423725-2020 серии: 03 04 I.Состав: 1.Иммуносорбент - 1 планшет.2.Контрольный положительный образец (К+) - 1 фл. (03 мл).3.Контрольн... (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
46189
Registration Number
РЗН 2020/11658
Registration Date
August 11, 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. ЗАО ЭКОлаб Россия 142530 Московская область г. Электрогорск ул. Буденного д. 1.