CovidEk Direct reagent kit for the qualitative detection of SARS-CoV-2 virus RNA in nasopharyngeal and oropharyngeal smears by RT-PCR in real time according to TU 21.20.23-132-70423725-2021 series 08 consisting of:1. RT-PCR reagent - 1 tube (05 ml) .2. COVID-19 primers - 1 tube (15... (see the full description in the card)
Russia·Unknown·CJSC EKOlab·Registered June 22, 2022·Class 3- Device Name (English)
- CovidEk Direct reagent kit for the qualitative detection of SARS-CoV-2 virus RNA in nasopharyngeal and oropharyngeal smears by RT-PCR in real time according to TU 21.20.23-132-70423725-2021 series 08 consisting of:1. RT-PCR reagent - 1 tube (05 ml) .2. COVID-19 primers - 1 tube (15... (see the full description in the card)
- Device Name (Russian)
- Набор реагентов КовидЭк Директ для качественного выявления РНК вируса SARS-CoV-2 в назо- и орофарингеальных мазках методом ОТ-ПЦР в режиме реального времени по ТУ 21.20.23-132-70423725-2021 серия 08 в составе:1. ОТ-ПЦР-реагент - 1 пробирка (05 мл).2. Праймеры COVID-19 - 1 пробирка (15... (см. в карточке полное описание)
- Device Type (English)
- N/A
- Device Type (Russian)
- Unknown
- Risk Class
- Class 3
- OKPD Code
- 21.20.23.110
- Registry Key
- 64517
- Registration Number
- РЗН 2022/17557
- Registration Date
- June 22, 2022
- Validity Period
- January 01, 2025
- 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. Закрытое акционерное общество ЭКОлаб Россия 142530 Московская область г. Электрогорск ул. Буденного д 1..2. Закрытое акционерное общество ЭКОлаб Россия 142530 Московская область г. Электрогорск ул. Буденного д. 1а.
Access comprehensive regulatory information for CovidEk Direct reagent kit for the qualitative detection of SARS-CoV-2 virus RNA in nasopharyngeal and oropharyngeal smears by RT-PCR in real time according to TU 21.20.23-132-70423725-2021 series 08 consisting of:1. RT-PCR reagent - 1 tube (05 ml) .2. COVID-19 primers - 1 tube (15... (see the full description in the card) in the Russia medical device market through Pure Global AI's free database. This Class 3 medical device is registered under Roszdravnadzor registration number РЗН 2022/17557 and manufactured by CJSC EKOlab. The device was registered on June 22, 2022.
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.