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Tag Archives: Inova Diagnostics—

FDA-cleared Inova Dx calprotectin test

Jan. 8, 2018—Inova Diagnostics announced the clearance of Quanta Flash Calprotectin by the FDA. Quanta Flash Calprotectin aids in the diagnosis of inflammatory bowel disease and helps differentiate IBD from irritable bowel syndrome. The assay provides precise quantification, with an analytical measurement range of up to 3,500 mg/kg, is available on Bio-Flash, a random access chemiluminescent instrument, and can be ...

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FDA-cleared ANCA assays, 5/17

May 2017—Inova Diagnostics announced that the FDA has granted 510(k) clearance for its Nova Lite DAPI ANCA (ethanol) and Nova Lite DAPI ANCA (formalin) kits for use with Nova View, a digital IFA microscope. Nova Lite DAPI ANCA kits detect anti-neutrophil cytoplasmic antibodies on an automated digital IFA microscope.

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FDA-cleared assay for rheumatoid arthritis, 12/15

December 2015—Inova Diagnostics announced the FDA clearance of Quanta Flash CCP3, an assay that aids in the diagnosis of rheumatoid arthritis. The fully automated chemiluminescent assay, which has demonstrated excellent clinical performance in large cohorts of RA and disease control patients, uses a third-generation cyclic citrullinated peptide technology from Inova Diagnostics.

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FDA clears automated digital IFA microscope

April 22, 2015—Inova Diagnostics announced the FDA has cleared Nova View, an automated digital indirect fluorescent assay microscope, through the de novo classification process. Nova View is the first FDA-cleared automated digital IFA microscope in the U.S. The Nova Lite DAPI ANA Kit, an IFA reagent indicated for use with Nova View, received 510(k) clearance at the same time. ANA ...

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Calprotectin assay, 8/14

August 2014—Inova Diagnostics announced the global launch of Quanta Lite Calprotectin, an FDA-cleared, quantitative ELISA that detects calprotectin levels, aids in the diagnosis of inflammatory bowel disease, and can also help differentiate, in conjunction with other laboratory and clinical findings, IBD from irritable bowel syndrome.

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RA biomarker, 3/13:75

Leiden University Medical Center and Inova Diagnostics have completed a worldwide license agreement for technology developed at LUMC to detect antibodies to carbamylated proteins (anti-CarP). This technology represents an important advance in diagnosing rheumatoid arthritis (RA).

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