EarlyCDT Lung Test Kit

Primary DI

50608852200668

Basic UDI-DI Code

506088522ECDTL26B

Reference

ECDTL2

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Freenome Ltd

The EarlyCDT Lung Test Kit is intended to be used as Immunoassay for the In Vitro detection of a panel of 7 lung cancer autoantibodies in humans to aid in the early detection of lung cancer in high risk patients and risk stratification of patients with indeterminate pulmonary nodules identified by CT.

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