HITAlert Kit

Primary DI

08719327450918

Basic UDI-DI Code

B-08719327450918

Reference

IQP-396

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

IQ Products BV

Immune heparin induced thrombocytopenia (HIT) is a distinct syndrome in which laboratory detection of the pathological HIT antibodies is diagnostically useful. The HITAlert™ Kit, a qualitative, rapid, non-automated and flow cytometric platelet activation assay, which detects antibodies based on their characteristic platelet-activating properties in venous blood samples of patients suspected of HIT. This HITAlert™ Kit should be used as a screening test and only be executed and interpreted by well-trained and authorized laboratory technicians. The results should always be used in conjunction with clinical findings and other serological tests.

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