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October 17, 2023
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FDA grants 510(k) clearance to Werfen’s reagent for connective tissue disease testing

The FDA has granted 510(k) clearance to Werfen for its Aptiva Connective Tissue Disease Essential reagent to assist in the diagnosis of patients with autoimmune diseases, according to a manufacturer press release.

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September 08, 2014
2 min read
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Lab-developed, commercial assays performed comparably in norovirus detection

WASHINGTON, D.C. — Four different assays for the detection of norovirus in stool specimens performed comparably, according to data presented at ICAAC 2014.