EpiDirect® MLH1 Methylation qPCR Assay

Primary DI

05713915001417

Basic UDI-DI Code

5713915ED002M2

Reference

8401;8400

Device Types

Single use New device

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

PentaBase A/S

EpiDirect® MLH1 Methylation qPCR Assay is a qualitative real-time polymerase chain reaction (PCR) assay intended to detect methylated DNA in the human mismatch repair gene MutL Homolog1 (MLH1) promoter. The assay is intended for use with purified genomic DNA (gDNA) samples that, without further pre-treatment, can be used with semi-automated real-time PCR systems to detect and quantify the methylation status of MLH1 promotor for research purposes. Samples should be extracted human gDNA from Formalin-Fixed Paraffin-Embedded (FFPE) biopsies and should be prepared using automated DNA extraction platforms or manual workflows. The device is For Research Use Only and may not be used in diagnostic procedures.

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