Fetal Cell Count Kit

Primary DI

08717953022332

Basic UDI-DI Code

B-08717953022332

Reference

IQP-363

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

IQ Products BV

The Fetal Cell Count™ Kit is intended for the discrimination and quantitative detection of human fetal red blood cells (fRBC) in maternal blood. This method used for diagnosis of Fetomaternal Hemorrhage (FMH) is applied to peripheral blood samples of pregnant women with abdominal trauma and/or suspected Rhesus D (RhD) incompatibility. The Fetal Cell Count™ Kit is based on a sensitive and accurate, non-automated flow cytometric method, which offers a dual fluorescent detection of two intracellular antigens, fetal hemoglobin (HbF) and carbonic anhydrase (CA). Both HbF and CA are detected in red blood cells obtained from EDTA anti-coagulated or heparin-treated human peripheral whole blood. The complete dual-color staining and analysis of up to 5 samples, that must be executed and interpreted by well-trained and authorized laboratory technicians, can be concluded within 90 minutes from blood collection.

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