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). - Roszdravnadzor Registration РЗН 2017/6293
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.

