EpiDirect® MGMT Methylation qPCR Assay

Organization name

PentaBase A/S

SRN

DK-MF-000023157

Manufacturer status

Active

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• CW009

  The buffers, primer/probe, and tubes are not to be reused.
• CW266

  EUDAMED did not publish a description for this code.

Primary placement in Denmark; available across 1 country total.

Trade name

EpiDirect® MGMT Methylation qPCR Assay

UDI-DI code

05713915000434

Basic UDI-DI

5713915ED001LY

Reference / catalog number

8300

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

48

Additional product description

EpiDirect® MGMT Methylation qPCR Assay is a real-time polymerase chain reaction (PCR) assay intended to detect and quantify the methylation status of the human O6-methylguanine-DNA methyltransferase (MGMT) gene promoter. The assay is intended for use with purified human genomic DNA extracted from formalin-fixed paraffin-embedded brain tumor samples that, without further pre-treatment, can be analysed directly by semi-automatic real-time PCR systems. The assay should be used quantitatively by applying the included standard curve. The methylation status of the MGMT promoter determined by the EpiDirect® MGMT Methylation qPCR assay can be used for stratification of brain tumor patients in accordance with current clinical guidelines. The assay is intended for use by healthcare professionals or qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR as well as proficient in handling biological samples.

Additional information URL

https://5ba.se/ed001

Clinical sizes

No clinical sizes registered for this device.

• W01060299TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER

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