MAIPA Assay

Primary DI

05430000412117

Basic UDI-DI Code

5430000412900006Q2

Reference

900006

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Advanced Practical Diagnostics

The MAIPA Assay is a qualitative in vitro diagnostic medical device intended for professional laboratory use for the detection and identification of anti-platelet antibodies in serum and plasma samples and for detecting autoantibodies bound to the platelets of the patient. The test is an aid in the diagnosis of patients with identified or suspected immunological platelet disorders like Fetal-Neonatal Allo-Immune Thrombocytopenia (FNAIT), Post-Transfusion Purpura (PTP), Platelet Refractoriness (PR) and Immune Thrombocytopenias. The MAIPA Assay is designed for manual use.

The Basic UDI-DI associated with this device has 4 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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