spinit®

Primary DI

D-540300NK

Basic UDI-DI Code

B-540300NK

Reference

540300

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

biosurfit SA

The spinit® HbA1c disc is a disposable in vitro diagnostic medical device. It is a single use test, used with the spinit® instrument to aid in diagnosing and monitoring diabetes and identifying patients at risk of developing diabetes by quantitatively determining the concentration of glycated haemoglobin A1c in capillary whole blood samples of human origin. As an alternative to capillary blood, venous whole blood of human origin can be used. This is a device for near-patient testing and is only to be use by healthcare professionals.

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