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BioArray Solutions Gets FDA Clearance for Bead Array Immunoassay

NEW YORK, June 15 (GenomeWeb News) - BioArray Solutions has received clearance from the US Food and Drug Administration for a bead array-based multiplexed immunoassay, the Warren, NJ-based company said today.

 

The 510(k) clearance covers the company's IgG BeadChip test system, an immunoassay for the simultaneous detection of six antibodies to different extractable nuclear antigens. The test will be used with BioArray's Array Imaging Ssystem, AIS 400, which employs a chip format for detection.

 

BioArray Solutions is currently developing other assays for protein and DNA analysis to run on its platform.

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