Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies

Primary DI

06924030400934

Basic UDI-DI Code

B-06924030400934

Reference

MB00173

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

HOB Biotech Group Corp., Ltd.

The HOB-LIA-ANA is for the qualitative measurement of 15 kinds of IgG class antinuclear antibodies against nRNP/Sm, Sm, SS-A/60kDa, SS-A/52kDa, SS-B/La, Scl-70, PM-Scl, Jo-1, CENP-B, PCNA, dsDNA, nucleosome, histone, P0 and AMA-M2 in human serum. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of autoimmune disease. Antinuclear antibodies (ANA) are autoantibodies of different specificity directed against antigens of the cell nucleus. In general, ANA can be divided into antibodies aiming at extractable nuclear antigens (ENA), non-extractable nuclear antigens and cytoplasmic located antigens. The detection of ANA and ENA antibodies is important for diagnosis of collagenosis, systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD) and other rheumatic diseases. In principle, every rheumatic disease is related to a characteristic ANA antibody pattern. The ANA Profile Line Immunoassay has been developed to detect such antibody profiles.

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