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Medical Devices / Submissions and Approvals

FDA Clears Binx Health Diagnostic for STDs

Aug. 14, 2019

The FDA granted Binx Health another 510(k) clearance for its Binx io platform, clearing the fully automated point-of-care test for chlamydia and gonorrhea.

The test uses polymerase chain reaction (PCR) amplification and electrochemical testing to detect the common STDs.

It delivers results in about a half hour, using vaginal swab samples that can be collected by a physician or by the patient.

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