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Medical Devices / Submissions and Approvals

InBios Cleared for Dengue Detection Kit

Sept. 14, 2018
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The FDA granted 510(k) clearance to InBios’ DENV Detect NS1 Elisa Kit, used for detection of the dengue virus in patients.

The antigen detection assay is used for presumptive clinical laboratory diagnosis of the Dengue virus and has not been cleared for testing blood or plasma donors.

The kit uses samples collected from patients within the first week of showing symptoms of dengue fever or dengue hemorrhagic fever to detect the presence of the dengue virus.

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