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FDA Clears Haemonetics’ Assay Cartridge for Viscoelastic Testing

Haemonetics received 510(k) clearance from the U.S. FDA for the TEG 6s hemostasis analyzer system Global Hemostasis-HN assay cartridge.

HemoSonics received Special 510(k) clearance from the U.S. FDA for the expanded use of arterial blood samples with its Quantra QStat Cartridge

Werfen announced 510(k) clearance of Aptiva Connective Tissue Disease (CTD) Essential reagent by the U.S. Food and Drug Administration (FDA).

HemoSonics announced its Quantra Hemostasis System received an Innovative Technology contract award from Vizient.

Diagnostica Stago Inc. announced 510(k) clearance of the Max Generation3 family of analyzers including STA R Max3and STA Compact Max3.