CARCINOEMBRYONIC ANTIGEN

Primary DI

06936791010017

Basic UDI-DI Code

B-06936791010017

Reference

AP0101-96

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Zhongshan Bio-Tech Co., Ltd.

This reagent kit is applicable for quantitative test of the content of carcino-embryonic antigen in human serum.Carcino-embryonic antigen (CEA) is a kind of glycoprotein with the molecular weight of 175-200 kDa and generally exists in the epithelial cells of embryonic endoderm. The CEA in human serum belongs to the broad-spectrum tumor markers. Its concentration is closely related to the cancers in various viscera, especially the colon cancer. CEA is not helpful to early test of tumor, but owns very high clinical value for identifying benign and malignant tumors. The CEA concentration in serum of tumor patients is related to the progress of tumors and the tracking and testing of CEA is helpful to the postoperative observation of tumor, and to estimate whether the operation is successful or not. This reagent kit is mainly used to dynamically monitor the malignant tumor patients and help determine the disease course and treatment effect in a supplementary way. It cannot be used as the basis of early diagnosis or confirmation of malignant tumors and is not suitable for the tumor screening of the common population.

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