AFP Assay kit CLIA

Primary DI

06974521000990

Basic UDI-DI Code

B-06974521000990

Reference

SUPM066036

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 alpha fetoprotein (AFP) in human serum and (or) plasma. Alpha fetoprotein (AFP) is a kind of single-chain glycoprotein whose molecular weight is about 70000 Dalton. AFP is extremely similar to albumin and they constitute two major types of protein of fetal blood circulation. AFP is mainly produced by fetal's liver and yolk bag and a little is distributed in other organs. 5 AFP can be detected in fetal's blood circulation about 30 days after pregnancy. The concentration of AFP reaches the maximum in 12-15 weeks in the gestation period and then it gradually declines until the delivery date. Only tiny AFP can be detected when a baby is 2 years old. When an adult is infected with a sexually transmitted disease or pregnant, the AFP level will rise again.

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