BioCLIA Autoimmune Reagent Kit, ENA Screen I

Primary DI

06924030415907

Basic UDI-DI Code

B-06924030415907

Reference

MY00147C

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, ENA Screen I assay is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to extractable nuclear antigens in human serum and plasma as an aid in the diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) or CREST syndrome. It is an in vitro diagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, ENA Screen I is intended for the calibration of the BioCLIA ENA Screen I performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, ENA Screen I is intended for the quality control purposes of the BioCLIA ENA Screen I 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).