BioCLIA Autoimmune Reagent Kit, Cardiolipin IgM

Primary DI

06924030415716

Basic UDI-DI Code

B-06924030415716

Reference

MY00122C

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, Cardiolipin IgM assay is intended for the in vitro semi-quantitative measurement of anti-Cardiolipin IgM antibodies in human serum and plasma as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders 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, Cardiolipin IgM is intended for the calibration of the BioCLIA Cardiolipin IgM performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, Cardiolipin IgM is intended for the quality control purposes of the BioCLIA Cardiolipin 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).