Reagent kit for the detection of Zika virus RNA by polymerase chain reaction method "FLAVISCRINE-ZIKV" for in vitro diagnostics according to TU 9398-801-17253567-2016 Composed of: 1. Set 1, consisting of: - solution 1 - 1 vial (45 ml); - solution 2 - 1 vial (40 ml); - solution 3 - 1 vial (100 ml); - solution 4 - 1 vial (40 ml); - sorbent - 3 test tubes (1 ml each); - solution for elution - 5 tubes (2 ml each). 2. Set 2, consisting of: - reaction mixture - 1 tube (1100 μl); - Taq polymerase (20 units/μl) - 1 tube (60 μl); - reverse transcriptase (100 u/μl) - 1 tube (12 μl); - diluent - 2 tubes (2 ml each); - dithiothreytol - 1 tube (15 μl); - ribonuclease inhibitor (20 U/μL) - 1 tube (60 μL); - VKO - 2 test tubes (20 μl each) lyophilized; - positive control sample - 2 test tubes (20 μl each) lyophilized; - Recovery solution - 2 test tubes (2 ml each).
Russia·109200·LLC NPF "Litekh"·Registered December 25, 2023·N/A- Device Name (English)
- Reagent kit for the detection of Zika virus RNA by polymerase chain reaction method "FLAVISCRINE-ZIKV" for in vitro diagnostics according to TU 9398-801-17253567-2016 Composed of: 1. Set 1, consisting of: - solution 1 - 1 vial (45 ml); - solution 2 - 1 vial (40 ml); - solution 3 - 1 vial (100 ml); - solution 4 - 1 vial (40 ml); - sorbent - 3 test tubes (1 ml each); - solution for elution - 5 tubes (2 ml each). 2. Set 2, consisting of: - reaction mixture - 1 tube (1100 μl); - Taq polymerase (20 units/μl) - 1 tube (60 μl); - reverse transcriptase (100 u/μl) - 1 tube (12 μl); - diluent - 2 tubes (2 ml each); - dithiothreytol - 1 tube (15 μl); - ribonuclease inhibitor (20 U/μL) - 1 tube (60 μL); - VKO - 2 test tubes (20 μl each) lyophilized; - positive control sample - 2 test tubes (20 μl each) lyophilized; - Recovery solution - 2 test tubes (2 ml each).
- Device Name (Russian)
- Набор реагентов для обнаружения РНК вируса Зика (Zika virus) методом полимеразной цепной реакции "ФЛАВИСКРИН-ZIKV" для диагностики in vitro по ТУ 9398-801-17253567-2016 в составе: 1. Комплект 1, в составе: - раствор 1 - 1 флакон (45 мл); - раствор 2 - 1 флакон (40 мл); - раствор 3 - 1 флакон (100 мл); - раствор 4 - 1 флакон (40 мл); - сорбент - 3 пробирки (по 1 мл); - раствор для элюции - 5 пробирок (по 2 мл). 2. Комплект 2, в составе: - реакционная смесь - 1 пробирка (1100 мкл); - Taq-полимераза (20 ед/мкл) - 1 пробирка (60 мкл) ; - обратная транскриптаза (100 ед/мкл) - 1 пробирка (12 мкл); - разбавитель - 2 пробирки (по 2 мл); - дитиотрейтол - 1 пробирка (15 мкл); - ингибитор рибонуклеаз (20 ед/мкл) - 1 пробирка (60 мкл); - ВКО - 2 пробирки (по 20 мкл) лиофилизированные; - положительный контрольный образец - 2 пробирки (по 20 мкл) лиофилизированные; - раствор для восстановления - 2 пробирки (по 2 мл).
- Device Type (English)
- N/A
- Device Type (Russian)
- 109200
- Risk Class
- N/A
- OKPD Code
- 21.20.23.110
- Registry Key
- 75862.0
- Registration Number
- РЗН 2017/6293
- Registration Date
- December 25, 2023
- Manufacturer Name (English)
- LLC NPF "Litekh"
- Manufacturer Name (Russian)
- ООО НПФ "Литех"
- Country (English)
- Russia
- Country (Russian)
- Россия
- Legal Address (English)
- NPF Litech LLC, 11 Pererva str., bldg. 29, Moscow, 109651, Russia
- Legal Address (Russian)
- ООО НПФ "Литех", Россия, 109651, г. Москва, ул. Перерва, д. 11, стр. 29
- Manufacturing Address
- 119435, Россия, Москва, ул. Малая Пироговская, д. 1, стр. 3
Access comprehensive regulatory information for Reagent kit for the detection of Zika virus RNA by polymerase chain reaction method "FLAVISCRINE-ZIKV" for in vitro diagnostics according to TU 9398-801-17253567-2016 Composed of: 1. Set 1, consisting of: - solution 1 - 1 vial (45 ml); - solution 2 - 1 vial (40 ml); - solution 3 - 1 vial (100 ml); - solution 4 - 1 vial (40 ml); - sorbent - 3 test tubes (1 ml each); - solution for elution - 5 tubes (2 ml each). 2. Set 2, consisting of: - reaction mixture - 1 tube (1100 μl); - Taq polymerase (20 units/μl) - 1 tube (60 μl); - reverse transcriptase (100 u/μl) - 1 tube (12 μl); - diluent - 2 tubes (2 ml each); - dithiothreytol - 1 tube (15 μl); - ribonuclease inhibitor (20 U/μL) - 1 tube (60 μL); - VKO - 2 test tubes (20 μl each) lyophilized; - positive control sample - 2 test tubes (20 μl each) lyophilized; - Recovery solution - 2 test tubes (2 ml each). in the Russia medical device market through Pure Global AI's free database. This medical device is registered under Roszdravnadzor registration number РЗН 2017/6293 and manufactured by LLC NPF "Litekh". The device was registered on December 25, 2023.
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.