BioCLIA Autoimmune Reagent Kit, RF IgG

Primary DI

06924030415785

Basic UDI-DI Code

B-06924030415785

Reference

MY00129C

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, RF IgG assay is intended for the in vitro semi-quantitative measurement of Rheumatoid Factor G (RF-IgG) in human serum and plasma as an aid in the diagnosis of rheumatoid arthritis (RA) or other related diseases 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, RF IgG is intended for the calibration of the BioCLIA RF IgG performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Calibrator Set, RF IgG is intended for the calibration of the BioCLIA RF IgG 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).