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Home › Business, Policy & Funding › Regulatory News & FDA Approvals › Chembio Diagnostics Plans FDA Submission for HIV-Syphilis Test in Q1 2018

Chembio Diagnostics Plans FDA Submission for HIV-Syphilis Test in Q1 2018

Dec 21, 2017
|
staff reporter

NEW YORK (360Dx) – Chembio Diagnostics said today that it plans to submit a pre-market approval application with the US Food and Drug Administration during the first quarter of 2018 to support commercialization of its first point-of-care HIV-syphilis assay in the US. 

The expected submission comes on the back of the firm completing a US clinical trial evaluating the system.

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