Diagnostic Kit for Carcinoembryonic Antigen (CEA) (Time-resolved Fluorescence Immunochromatographic Assay)

Primary DI

06974521003267

Basic UDI-DI Code

B-06974521003267

Reference

SUPF033025

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is suitable for in vitro quantitative detection of the concentration of carcinoembryonic antigen (CEA) in human serum, plasma or whole blood samples. Carcinoembryonic antigen (CEA), a glycoprotein with a molecular weight of 180,000, is a carcinoembryonic antigen produced during embryonic development. It is a carcinoembryonic antigen and exists in the fetus' intestines, pancreas and liver during the first two months of pregnancy. High CEA often indicates gastrointestinal cancer, which is common in colorectal cancer, pancreatic cancer, gastric cancer, breast cancer, lung cancer, and medullary thyroid cancer. CEA is a broad-spectrum tumor marker. Many benign diseases such as benign breast tumors, severe alcoholic liver cirrhosis, emphysema, collagen diseases, cardiovascular diseases, diabetes, non-specific colitis, etc., about 15% to 53% of patients with serum CEA will also increase Therefore, CEA is not a specific marker of malignant tumors, it is mainly of auxiliary value in diagnosis, and has greater clinical value for prognosis judgment and efficacy observation. Smokers have higher concentrations than non-smokers.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).