REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS

Primary DI

++G226DX474000%

Basic UDI-DI Code

++G226FFPEDNAPKit95

Reference

Dx47400

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Norgen Biotek Corporation

Norgen’s FFPE DNA Purification Kit Dx provides a rapid method for the isolation and purification of genomic DNA from formalin-fixed paraffin-embedded (FFPE) tissue samples for subsequent in vitro diagnostic use. Using formalin to fix tissues leads to crosslinking of the nucleic acids and proteins, and the process of embedding the tissue samples can also lead to fragmentation of the DNA over time. Norgen’s FFPE DNA Purification Kit Dx provides conditions that allow for the partial reversing of the formalin modifications, resulting in a high quality and yield of DNA. Purification is based on spin column chromatography using Norgen’s proprietary resin as the separation matrix. The DNA is preferentially purified from other cellular components without the use of phenol or chloroform.

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