BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR

Primary DI

06974454727926

Basic UDI-DI Code

697445472V23005X00667

Reference

CWX006M-H

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Jiangsu CoWin Biotech Co., Ltd.

Cell-Free DNA Storage Tube is a direct draw whole blood collection tube intended for collection, transport and storage of blood samples. This device also stabilizes and preserves Cell-Free DNA in whole blood. Cell-Free DNA (cfDNA) is a DNA fragment derived from apoptosis or necrosis, free from extracellular cells, and is widely found in human serum, plasma, cerebrospinal fluid, urine, or saliva. Currently, cfDNA has been used as a new biomarker in clinical areas of prenatal diagnosis, tumor detection, post-organ transplant rejection, and infection detection. The Cell-Free DNA Storage Tube is intended for use by qualified clinical personnel in vitro diagnostic procedures.

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