Reagent kit for the detection of hepatitis C virus RNA (HCV) and its genotyping by reverse transcription and polymerase chain reaction (RT-HEPATHOGEN-C GENOTYPE) according to TU 9398-017-46482062-2008 A set of reagents for the isolation of nucleic acids ("Proba-NK"), including: - lysis solution - 1 vial (15 ml); - precipitation reagent - 1 vial (20 ml); - rinsing solution No1 - 1 vial (25 ml); - rinsing solution No2 - 1 vial (15 ml); - Dissolution buffer - 2 tubes (1.25 ml each); - negative control sample - 1 tube (1.5 ml each); - Internal control sample (RNA-BK) (~500 copies of RNA/μL) - 1 tube (500 μL); - internal control sample (DNA-BK) (~500 copies of DNA/μl) - 1 tube (500 μl); A set of reagents for reverse transcription of RNA, including: - Buffer solution for reverse transcription "OT-buffer" - 1 tube (100 μl); - a mixture of deoxynucleotide triphosphates (dNTP) and a primer for reverse transcription "primer OT-HCV+dNTP" - 1 tube (50 μL); - reverse transcriptase - 1 tube (25 μl); A set of reagents for PCR amplification, including: - Amplification mixture sealed with paraffin: - "Hepatitis C virus (HCV), HCV-general" - 50 tubes (20 μl each); - "Hepatitis C virus (HCV), type 1a" - 50 tubes (20 μl each); - "Hepatitis C virus (HCV), type 1b" - 50 tubes (20 μl each); - "Hepatitis C virus (HCV), type 2" - 50 tubes (20 μl each); - "Hepatitis C virus (HCV), type 3a/3b" - 50 tubes (20 μl each); - Buffer solution "PCR-buffer" - 5 tubes (500 μl each); - Taq polymerase (5 U/μL) - 2 tubes (50 μl each) and 1 tube (25 μl); - mineral oil - 5 test tubes (1.0 ml each); - positive control samples (K+): - HCV-General, 75 μL 1 tube; - HCV, Type 1a, 75 μL 1 tube; - HCV, Type 1b, 75 μL, 1 tube; - HCV, Type 2, 75 μL 1 tube; - HCV, 3a/3b type, 75 μL 1 tube. - Roszdravnadzor Registration ФСР 2009/04071

Access comprehensive regulatory information for Reagent kit for the detection of hepatitis C virus RNA (HCV) and its genotyping by reverse transcription and polymerase chain reaction (RT-HEPATHOGEN-C GENOTYPE) according to TU 9398-017-46482062-2008 A set of reagents for the isolation of nucleic acids ("Proba-NK"), including: - lysis solution - 1 vial (15 ml); - precipitation reagent - 1 vial (20 ml); - rinsing solution No1 - 1 vial (25 ml); - rinsing solution No2 - 1 vial (15 ml); - Dissolution buffer - 2 tubes (1.25 ml each); - negative control sample - 1 tube (1.5 ml each); - Internal control sample (RNA-BK) (~500 copies of RNA/μL) - 1 tube (500 μL); - internal control sample (DNA-BK) (~500 copies of DNA/μl) - 1 tube (500 μl); A set of reagents for reverse transcription of RNA, including: - Buffer solution for reverse transcription "OT-buffer" - 1 tube (100 μl); - a mixture of deoxynucleotide triphosphates (dNTP) and a primer for reverse transcription "primer OT-HCV+dNTP" - 1 tube (50 μL); - reverse transcriptase - 1 tube (25 μl); A set of reagents for PCR amplification, including: - Amplification mixture sealed with paraffin: - "Hepatitis C virus (HCV), HCV-general" - 50 tubes (20 μl each); - "Hepatitis C virus (HCV), type 1a" - 50 tubes (20 μl each); - "Hepatitis C virus (HCV), type 1b" - 50 tubes (20 μl each); - "Hepatitis C virus (HCV), type 2" - 50 tubes (20 μl each); - "Hepatitis C virus (HCV), type 3a/3b" - 50 tubes (20 μl each); - Buffer solution "PCR-buffer" - 5 tubes (500 μl each); - Taq polymerase (5 U/μL) - 2 tubes (50 μl each) and 1 tube (25 μl); - mineral oil - 5 test tubes (1.0 ml each); - positive control samples (K+): - HCV-General, 75 μL 1 tube; - HCV, Type 1a, 75 μL 1 tube; - HCV, Type 1b, 75 μL, 1 tube; - HCV, Type 2, 75 μL 1 tube; - HCV, 3a/3b type, 75 μL 1 tube. in the Russia medical device market through Pure Global AI's free database. This Class 2b medical device is registered under Roszdravnadzor registration number ФСР 2009/04071 and manufactured by DNA-Technology TS LLC. The device was registered on August 07, 2024.

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.