June 2024—HemoSonics received special 510(k) clearance from the FDA for the expanded use of arterial blood samples with its Quantra QStat cartridge. The QStat cartridge used with the Quantra hemostasis analyzer first received 510(k) clearance in 2022 for use in venous whole blood samples.
The Quantra hemostasis system consists of the Quantra analyzer with QPlus and QStat cartridges and is FDA cleared for use in point-of-care settings. Results are typically available in less than 15 minutes.
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