Neonatal Toxoplasma gondii IgM FEIA

Primary DI

06438172116016

Basic UDI-DI Code

B-06438172116016

Reference

6199802

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd Annex 2 List B

Status

On The Market

Manufacturer

Labsystems Diagnostics Oy

This Neonatal Toxoplasma gondii IgM FEIA kit is intended for the determination of IgM-class antibodies to Toxoplasma gondii in blood samples dried on filter paper. The test is intended as a primary method for screening of newborns for congenital toxoplasmosis (CT). Because IgM-class antibodies due to their high molecular weight do not cross placenta, determination of specific antibodies in newborn samples taken shortly after birth indicates exposure of the fetus intra utero to Toxoplasma gondii. Cases showing elevated levels of specific antibodies should be further investigated.

Other on-the-market devices with the same classification (Eu Ivd Annex 2 List B) and regulation (EU IVDD).