Baebies obtained 510(k) clearance and a CLIA waiver for a triplex respiratory test on its Finder point-of-care system, enabling molecular testing alongside other cleared modalities. The instrument is designed for rapid qPCR detection of influenza A, influenza B, and SARS-CoV-2, with optional endpoint PCR capability and higher multiplexing potential than many competing rapid systems. The clearance extends Baebies’ platform differentiation: it combines spatial thermal cycling and cartridge architectures to move reaction droplets through temperature and detection zones, supporting multiplex chains in a single workflow. For hospitals and near-patient testing programs, CLIA-waived molecular panels can reduce lab turnaround time and increase throughput while supporting infection-control decisions earlier in patient pathways.
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