NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS

Primary DI

08809054870384

Basic UDI-DI Code

88090548717188-48V4

Reference

17188-48

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

iNtRON Biotechnology

This technical construction file consists of technical documentation related to Nucleic acid extraction system using by Automated nucleic acid extractor. The AutoXT Total gDNA Kit is used with the Miracle-AutoXT Nucleic Acid Extraction System (IMC-NC15PLUS) to purify gDNA of pathogens such as bacteria and virus from fresh / frozen blood, serum, other cell-free body fluids, virus culture, cultivated cell, tissue homogenate and stool swab homogenate. gDNA are easily bound to the surface of the magnetic beads and release using a proprietary buffer system. It meet the requirements of the In-Vitro Medical Device Regulation 2017/746 and is requested to bear the CE mark to enable them to move freely within the European Community and to be put into service in accordance with its intended purpose.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).