BioCLIA Autoimmune Reagent Kit, RF IgM

Primary DI

06924030415792

Basic UDI-DI Code

B-06924030415792

Reference

MY00130C

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 IgM assay is intended for the in vitro quantitative measurement of Rheumatoid Factor M (RFIgM) 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 IgM is intended for the calibration of the BioCLIA RF IgM performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, RF IgM is intended for the quality control purposes of the BioCLIA RF IgM 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).