Reagent kit "DS-ELISA-ANTI-HCV-SPECTRUM-GM" Enzyme immunoassay system for detecting the spectrum of antibodies of IgG and IgM class to the hepatitis C virus and confirming the results of anti-HCV screening according to TU 9398-095-05941003-2013 Composed of: - immunosorbent; - conjugate (concentrate); - K- - negative control sample; - K+ - positive control sample; - RRB - solution for diluting the conjugate; - BR block solution for working dilution of serums; - PR (concentrate x 25) - flushing solution; - stop reagent; - TMB-Substrate solution, ready for use (when completing the set TMB-substrate solution); or - SB-substrate buffer solution; - TMB-chromogen-3,3', 5,5'-tetramethylbenzidine.
Russia·286460·LLC "NPO "Diagnostic Systems"·Registered April 05, 2022·N/A- Device Name (English)
- Reagent kit "DS-ELISA-ANTI-HCV-SPECTRUM-GM" Enzyme immunoassay system for detecting the spectrum of antibodies of IgG and IgM class to the hepatitis C virus and confirming the results of anti-HCV screening according to TU 9398-095-05941003-2013 Composed of: - immunosorbent; - conjugate (concentrate); - K- - negative control sample; - K+ - positive control sample; - RRB - solution for diluting the conjugate; - BR block solution for working dilution of serums; - PR (concentrate x 25) - flushing solution; - stop reagent; - TMB-Substrate solution, ready for use (when completing the set TMB-substrate solution); or - SB-substrate buffer solution; - TMB-chromogen-3,3', 5,5'-tetramethylbenzidine.
- Device Name (Russian)
- Набор реагентов "ДС-ИФА-АНТИ-HCV-СПЕКТР-GM" Тест-система иммуноферментная для выявления спектра антител класса IgG и IgM к вирусу гепатита С и подтверждения результатов анти-HCV скрининга по ТУ 9398-095-05941003-2013 в составе: - иммуносорбент; - конъюгат (концентрат); - К- - контрольный отрицательный образец; - К+ - контрольный положительный образец; - РРК - раствор для разведения конъюгата; - БР-блок-раствор для рабочего разведеия сывороток; - ПР (концентрат х 25) - промывочный раствор; - стоп-реагент; - ТМБ-Субстратный раствор, готовый к применению (при комплектации набора ТМБ-Субстратным раствором); или - СБ-субстратный буферный раствор; - ТМБ-хромоген- 3,3`, 5,5`- тетраметилбензидин.
- Device Type (English)
- N/A
- Device Type (Russian)
- 286460
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 61807.0
- Registration Number
- ФСР 2008/03021
- Registration Date
- April 05, 2022
- Manufacturer Name (English)
- LLC "NPO "Diagnostic Systems"
- Manufacturer Name (Russian)
- ООО "НПО "Диагностические системы"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- 1. NPO Diagnostic Systems LLC, 22 Yablunevaya St., Nizhny Novgorod, 603093, Russia. 2. NPO Diagnostic Systems LLC, 9B Barminskaya St., Nizhny Novgorod, 603022, Russia.
- Legal Address (Russian)
- 1. ООО "НПО "Диагностические системы", Россия, 603093, г. Нижний Новгород, ул. Яблоневая, д. 22. 2. ООО "НПО "Диагностические системы", Россия, 603022, г. Нижний Новгород, ул. Барминская, д. 9Б.
- Manufacturing Address
- 603093, Россия, г. Нижний Новгород, ул. Яблоневая, д. 22, а/я 69
Access comprehensive regulatory information for Reagent kit "DS-ELISA-ANTI-HCV-SPECTRUM-GM" Enzyme immunoassay system for detecting the spectrum of antibodies of IgG and IgM class to the hepatitis C virus and confirming the results of anti-HCV screening according to TU 9398-095-05941003-2013 Composed of: - immunosorbent; - conjugate (concentrate); - K- - negative control sample; - K+ - positive control sample; - RRB - solution for diluting the conjugate; - BR block solution for working dilution of serums; - PR (concentrate x 25) - flushing solution; - stop reagent; - TMB-Substrate solution, ready for use (when completing the set TMB-substrate solution); or - SB-substrate buffer solution; - TMB-chromogen-3,3', 5,5'-tetramethylbenzidine. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number ФСР 2008/03021 and manufactured by LLC "NPO "Diagnostic Systems". The device was registered on April 05, 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.