AFP IRMA KIT

Primary DI

15099590214661

Basic UDI-DI Code

150995905AFPIRMAN4

Reference

IM1441

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

IMMUNOTECH s.r.o.

AFP IRMA KIT is an in vitro diagnostic manual medical device intended to be used by healthcare professionals for the quantitative measurement of AFP in human serum and amniotic fluid. Measurement of AFP is intended to be used as aid in diagnosis and monitoring of ovarian germ cell tumors in women; as aid in diagnosis, prognosis and monitoring of testicular germ cell tumors in men; as an aid in diagnosis of hepatocellular cancer in high-risk population, and for prognosis and monitoring of hepatocellular cancer in general population; in risk assessment of neural tube defect and, in conjunction with other screening markers (hCG, uE3, …), in risk assessment of Down syndrome (trisomy 21) in the 2nd trimester of pregnancy.

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