AmoyDx® AutoExtract Kit (FFPE DNA/RNA)

Trade name

AmoyDx® AutoExtract Kit (FFPE DNA/RNA)

UDI-DI code

06959094214692

Basic UDI-DI

69590942A0035GK

Reference / catalog number

8.02.0145

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The AmoyDx® AutoExtract Kit (FFPE DNA/RNA) is intended for the isolation and purification of high-quality DNA and RNA from formalin-fixed, paraffin-embedded (FFPE) tissue samples. The purified DNA and RNA are suitable for downstream molecular applications, including reverse transcription PCR (RT-PCR), real-time PCR (qPCR), and next-generation sequencing (NGS). This kit must be used in conjunction with the AmoyDx Nucleic Acid Extraction System and is intended for use by trained professionals in a controlled laboratory environment.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W050299DEVICES FOR SAMPLES TRANSPORT - OTHER

1 warning recorded — scroll inside the panel to see all entries.

• CW009

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.