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Inova Diagnostics IgG Antibody Determination Kit for Lupus Nabs FDA Clearance

NEW YORK – Inova Diagnostics announced on Tuesday that its Nova Lite DAPI dsDNA Crithidia luciliae Kit has received 510(k) clearance from the US Food and Drug Administration.

The kit is used to help in the qualitative and semi-quantitative determination of anti-double stranded DNA (dsDNA) IgG antibodies using Inova's Nova View Automated Fluorescence Microscope or manual fluorescence microscopy. The presence of these antibodies, along with other serological and clinical findings, can help clinicians diagnose systemic lupus erythematosus, the company said in a statement. 

Used with the Nova View Automated Fluorescence Microscope, the kit can improve laboratory turnaround time, as well as reduce hands-on time with the detection and titering of anti-dsDNA antibodies due to its single-well titer application, the San Diego, California-based company added.