NEOSICKLE NS540_BR

Primary DI

03770024008005

Basic UDI-DI Code

3770024008NEOSICKLEBW

Reference

S227-49502-55

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

BIOMANEO

The device NeoSickle is an in vitro diagnostic medical device intended for the screening by mass spectrometry of major sickle cell syndrome or sickle cell trait, by detecting the presence of the "S" mutated beta haemoglobin (Hb) chain and/or the absence of the "A" non-mutated beta haemoglobin chain from dried blood samples. This device includes the software eNeoSickle. The variant NeoSickle NS540 is for high-throughput automated sickle cell screening.

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).