Reagent kit for the determination of genetic polymorphisms associated with the risk of oncopathology by polymerase chain reaction (OncoGenetics) according to TU 9398-030-46482062-2011 1. OncoGenetics BRCA, Packaging N: - Amplification mixtures (8 items): BRCA1: 185delAG - 1 tube (960 μL); BRCA1: 4153delA - 1 tube (960 μL); BRCA1: 5382insC - 1 tube (960 μL); BRCA1: 3819delGTAAA - 1 tube (960 μL); BRCA1: 3875delGTCT - 1 tube (960 μL); BRCA1: 300 T>G (Cys61Gly) - 1 tube (960 μL); BRCA1: 2080delA - 1 tube (960 μL); BRCA2: 6174delT - 1 tube (960 μL); - TexnoTaq MAX polymerase - 1 tube (200 μl); - PCR buffer - 4 tubes (1.0 ml each); - Mineral oil - 1 bottle (8.0 ml); - K+1 [homozygous for normal allele] - 1 tube (270 μl); - K+2 [heterozygous] - 1 tube (270 μL). 2. OncoGenetics BRCA, Packaging A: - Mixtures for amplification Stream - 2 strips of 8 tubes (120 μl each); - Polymerase TexnoTaq MAX - 2 tubes (60 μl each); - PCR buffer Stream - 2 tubes (600 μl each); - Buffer for DNA dilution - 4 tubes (1.0 ml each); - K+1 [homozygous for normal allele] - 2 tubes (100 μl each); - K+2 [heterozygous] - 2 tubes (100 μl each); - Strips of 8 tubes - 10 pcs. - Roszdravnadzor Registration ФСР 2010/08415

Access comprehensive regulatory information for Reagent kit for the determination of genetic polymorphisms associated with the risk of oncopathology by polymerase chain reaction (OncoGenetics) according to TU 9398-030-46482062-2011 1. OncoGenetics BRCA, Packaging N: - Amplification mixtures (8 items): BRCA1: 185delAG - 1 tube (960 μL); BRCA1: 4153delA - 1 tube (960 μL); BRCA1: 5382insC - 1 tube (960 μL); BRCA1: 3819delGTAAA - 1 tube (960 μL); BRCA1: 3875delGTCT - 1 tube (960 μL); BRCA1: 300 T>G (Cys61Gly) - 1 tube (960 μL); BRCA1: 2080delA - 1 tube (960 μL); BRCA2: 6174delT - 1 tube (960 μL); - TexnoTaq MAX polymerase - 1 tube (200 μl); - PCR buffer - 4 tubes (1.0 ml each); - Mineral oil - 1 bottle (8.0 ml); - K+1 [homozygous for normal allele] - 1 tube (270 μl); - K+2 [heterozygous] - 1 tube (270 μL). 2. OncoGenetics BRCA, Packaging A: - Mixtures for amplification Stream - 2 strips of 8 tubes (120 μl each); - Polymerase TexnoTaq MAX - 2 tubes (60 μl each); - PCR buffer Stream - 2 tubes (600 μl each); - Buffer for DNA dilution - 4 tubes (1.0 ml each); - K+1 [homozygous for normal allele] - 2 tubes (100 μl each); - K+2 [heterozygous] - 2 tubes (100 μl each); - Strips of 8 tubes - 10 pcs. 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 2010/08415 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.