Roche Receives 510(k) Clearance & CLIA Waiver for Cobas Liat Multiplex Assay Panels to Diagnose Sexually Transmitted Infections
Shots:
- The US FDA has granted 510(k) clearance & CLIA waiver for Cobas liat STI multiplex assay panels (CT/NG & CT/NG/MG), commercially available under the CE mark in upcoming months
- The CT/NG (chlamydia & gonorrhea) & CT/NG/MG (chlamydia, gonorrhea & Mycoplasma genitalium) assays compliment the existing portfolio of singleplex & multiplex tests of Cobas liat for a variety of pathogens incl. SARS-CoV-2, influenza A/B, Strep A., & C. diff
- These panels enable easy & rapid diagnoses of multiple STIs with a single sample using gold-standard PCR technology to produce the results within ≤20 min
Ref: Globenewswire | Image: Roche
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