CEA Assay kit CLIA

Primary DI

06974521001065

Basic UDI-DI Code

B-06974521001065

Reference

SUPM067072

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shenzhen Superbio Technology Co.,Ltd.

This kit is used for in vitro quantitative detection of carcino-embryonic antigen (CEA) in human serum and (or) plasma. Carcino-embryonic antigen (CEA) was first described by Gold and Freedman in 1965 and is separated from hepatic metastases of colonic adenocarcinoma and extract of normal fetus digestive tract. CEA is considered a kind of antigen related to human tumor upon extensive investigation. A group of immune dopping glycoprotein contains about 200000 Dalton CEA, of which carbohydrate accounts for 50-85%. CEA is a member of immunoglobulin superfamily and it functions on cell adhesion molecule in serum. Determination of serum CEA is of great significance for prognosis and treatment of patients with malignant diseases, especially patients with colorectal cancer. Continuous determination can monitor such phenomena as progression, regression or recurrence of cancer of patients who have been treated. If the CEA content still continues to rise after treatment or surgical treatment, it means that the disease has not been treated or reoccurred. If the CEA content decreases, it means that intervention succeeds in the normal range. The content of CEA in the serum of patients with non-malignant diseases and who smoke like a chimney may rise, so CEA cannot be used for diagnosis of cancer or screening of patients without symptoms.

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