BioCLIA Autoimmune Reagent Kit,CTD Screen

Primary DI

06924030415914

Basic UDI-DI Code

B-06924030415914

Reference

MY00980C

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, CTD Screen assay is intended for the in vitro semi-quantitative measurement of autoantibodies to Sm, dsDNA, Nucleosome, Histone, Ribosomal-P, PCNA, Ro60, Ro52, SS-B/La, Scl-70, Jo-1, PM/Scl, CENP-B, nRNP/Sm and AMA-M2 in human serum and plasma on the fully automatic BioCLIA instrument. The kit is applied as an aid in the diagnosis of connective tissue diseases such as Sjögren's syndrome, systemic lupus erythematosus (SLE), CREST syndrome, Systemic Sclerosis, Polymyositis/Dermatomyositis, Primary Biliary Cirrhosis and so forth. It is an in vitro diagnostic medical device intended for laboratory professional use. The BioCLIA Autoimmune Calibrator Set, CTD Screen is intended for the calibration of the BioCLIA CTD Screen performed on the BioCLIA 6500 and BioCLIA 500. The BioCLIA Autoimmune Control Set, CTD Screen is intended for the quality control purposes of the BioCLIA CTD Screen 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).