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Medical Devices / Submissions and Approvals

FDA Clears Binx Health Diagnostic for STDs

Aug. 14, 2019
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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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