BioCLIA Autoimmune Reagent Kit, CTD Screen

Primary DI

06924030405281

Basic UDI-DI Code

B-06924030405281

Reference

MY00969

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.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).