extendSURETM Haemoglobin F and A2 Calibrators

Primary DI

09421902348044

Basic UDI-DI Code

B-09421902348044

Reference

HB110SCALAr

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Canterbury Scientific Limited

The extendSURETM Haemoglobin F and A2 Calibrators is intended for the calibration of HbA2 and HbF for use with Adams A1c HA-8160 (Diabetes monitoring and β-Thalassaemia screening mode; HA-8160 (TP mode)) and HA-8180T. This program consists of the routine assay of these calibrators by trained laboratory personnel and evaluation of the documented results against laboratory acceptable limits. For specific application in a particular assay refer to the analyser's operating manual or sheet. The calibrator is not to be used as a control

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