HIV Seroconversion Panel Reagent Kit as per TU 9398-215-05941003-2013 Version I: - "HIV seroconversion panel" is a set of blood serum (plasma) samples of one donor, during the period of development of HIV seroconversion, the presence of HBsAg, antibodies to the hepatitis C virus is allowed; - "Sample kit in liquid form - ready-to-use, transparent or slightly opalescent, colorless or yellowish liquid" (no more than 8 vials); - instructions for use; -passport. Execution II: - "HIV seroconversion panel" is a set of blood serum (plasma) samples of one donor, during the period of development of HIV seroconversion, the presence of HBsAg, antibodies to the hepatitis C virus is allowed; - "Set of samples in lyophilized form - dry porous masses of white or yellowish color" (no more than 8 vials); - instructions for use; -passport.
Russia·110210·LLC "NPO "Diagnostic Systems"·Registered April 05, 2022·N/A- Device Name (English)
- HIV Seroconversion Panel Reagent Kit as per TU 9398-215-05941003-2013 Version I: - "HIV seroconversion panel" is a set of blood serum (plasma) samples of one donor, during the period of development of HIV seroconversion, the presence of HBsAg, antibodies to the hepatitis C virus is allowed; - "Sample kit in liquid form - ready-to-use, transparent or slightly opalescent, colorless or yellowish liquid" (no more than 8 vials); - instructions for use; -passport. Execution II: - "HIV seroconversion panel" is a set of blood serum (plasma) samples of one donor, during the period of development of HIV seroconversion, the presence of HBsAg, antibodies to the hepatitis C virus is allowed; - "Set of samples in lyophilized form - dry porous masses of white or yellowish color" (no more than 8 vials); - instructions for use; -passport.
- Device Name (Russian)
- Набор реагентов "Сероконверсионная панель ВИЧ" по ТУ 9398-215-05941003-2013 Исполнение I: - «Сероконверсионная панель ВИЧ» набор образцов сывороток (плазмы) крови одного донора, в период развития у него сероконверсии к ВИЧ, допускается наличие HBsAg, антител к вирусу гепатита С.; - «Набор образцов в жидкой форме - готовые к употреблению, прозрачные или слегка опалесцирующие бесцветные или жёлтоватого оттенка жидкости» (не более 8 флаконов); - инструкция по применению; - паспорт. Исполнение II: - «Сероконверсионная панель ВИЧ» набор образцов сывороток (плазмы) крови одного донора, в период развития у него сероконверсии к ВИЧ, допускается наличие HBsAg, антител к вирусу гепатита С.; - «Набор образцов в лиофилизированной форме - сухие пористые массы белого или желтоватого цвета» (не более 8 флаконов).; - инструкция по применению; - паспорт.
- Device Type (English)
- N/A
- Device Type (Russian)
- 110210
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 61805.0
- Registration Number
- РЗН 2014/1634
- 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 HIV Seroconversion Panel Reagent Kit as per TU 9398-215-05941003-2013 Version I: - "HIV seroconversion panel" is a set of blood serum (plasma) samples of one donor, during the period of development of HIV seroconversion, the presence of HBsAg, antibodies to the hepatitis C virus is allowed; - "Sample kit in liquid form - ready-to-use, transparent or slightly opalescent, colorless or yellowish liquid" (no more than 8 vials); - instructions for use; -passport. Execution II: - "HIV seroconversion panel" is a set of blood serum (plasma) samples of one donor, during the period of development of HIV seroconversion, the presence of HBsAg, antibodies to the hepatitis C virus is allowed; - "Set of samples in lyophilized form - dry porous masses of white or yellowish color" (no more than 8 vials); - instructions for use; -passport. in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2014/1634 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.