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NEW YORK – Binx Health said on Thursday it has received a second 510(k) clearance from the US Food and Drug Administration for the Binx io molecular point-of-care platform for the detection of chlamydia and gonorrhea in male urine specimens.

The agency cleared the system in August 2019 for use with clinician and self-collected vaginal swab specimens.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.