BioCLIA Autoimmune Reagent Kit, AMA-M2

Primary DI

06924030415679

Basic UDI-DI Code

B-06924030415679

Reference

MY00118C

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

HOB Biotech Group Corp., Ltd.

The BioCLIA Autoimmune Reagent Kit, AMA-M2 assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to AMA-M2 in human serum and plasma as an aid in the diagnosis of autoimmune liver diseases (ALD) in conjunction with other laboratory and clinical findings. It is an in vitro diagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, AMA-M2 is intended for the calibration of the BioCLIA DGP IgA performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, AMA-M2 is intended for the quality control purposes of the BioCLIA AMA-M2 performed on the BioCLIA 6500 and BioCLIA 500. For professional in vitro diagnostic use only.

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