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See today's BioWorld MedTech
Home » Roche receives FDA approval for STI point-of-care tests
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Roche receives FDA approval for STI point-of-care tests

Jan. 22, 2025
By Shani Alexander
Roche AG secured U.S. FDA 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The tests, which also received a Clinical Laboratory Improvement Amendments waiver, will enable clinicians to detect several STIs including chlamydia, gonorrhea and Mycoplasma genitalium, in as little as 20 minutes.
BioWorld MedTech Regulatory Infection Diagnostics U.S. FDA

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