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SARS-CoV-2 Coronavirus RNA Reagent Detection Kit by RT-PCR with Real-Time Fluorescence Detection Intifica SARS-CoV-2-mono series E001 versions:I. Form 1 consisting of:1. Set of reagents for RT-PCR - 1 pc. consisting of:1.1. Mono-SC2 - 1 tube (10... (see the full description in the card) - Roszdravnadzor Registration РЗН 2020/12268

Access comprehensive regulatory information for SARS-CoV-2 Coronavirus RNA Reagent Detection Kit by RT-PCR with Real-Time Fluorescence Detection Intifica SARS-CoV-2-mono series E001 versions:I. Form 1 consisting of:1. Set of reagents for RT-PCR - 1 pc. consisting of:1.1. Mono-SC2 - 1 tube (10... (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 2020/12268 and manufactured by Alkor Bio Company Ltd.. The device was registered on October 14, 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 3
РЗН 2020/12268
SARS-CoV-2 Coronavirus RNA Reagent Detection Kit by RT-PCR with Real-Time Fluorescence Detection Intifica SARS-CoV-2-mono series E001 versions:I. Form 1 consisting of:1. Set of reagents for RT-PCR - 1 pc. consisting of:1.1. Mono-SC2 - 1 tube (10... (see the full description in the card)
Набор реагентов для выявления РНК коронавируса SARS-CoV-2 методом ОТ-ПЦР с флуоресцентной детекцией в режиме реального времени Интифика SARS-CoV-2-mono серия E001 варианты исполнения:I. Форма 1 в составе:1. Набор реагентов для ОТ-ПЦР - 1 шт. в составе:1.1. Mono-SC2 - 1 пробирка (10... (см. в карточке полное описание)
Roszdravnadzor Registration Number: РЗН 2020/12268
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Device Information
Device Name (English)
SARS-CoV-2 Coronavirus RNA Reagent Detection Kit by RT-PCR with Real-Time Fluorescence Detection Intifica SARS-CoV-2-mono series E001 versions:I. Form 1 consisting of:1. Set of reagents for RT-PCR - 1 pc. consisting of:1.1. Mono-SC2 - 1 tube (10... (see the full description in the card)
Device Name (Russian)
Набор реагентов для выявления РНК коронавируса SARS-CoV-2 методом ОТ-ПЦР с флуоресцентной детекцией в режиме реального времени Интифика SARS-CoV-2-mono серия E001 варианты исполнения:I. Форма 1 в составе:1. Набор реагентов для ОТ-ПЦР - 1 шт. в составе:1.1. Mono-SC2 - 1 пробирка (10... (см. в карточке полное описание)
Device Type (English)
N/A
Device Type (Russian)
Unknown
Risk Class
Class 3
OKPD Code
21.20.23.110
Registration Information
Registry Key
47635
Registration Number
РЗН 2020/12268
Registration Date
October 14, 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