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.
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Search Results for: point-of-care
Advanced Cardiovascular POC Testing System Gets FDA Clearance
Analytics for Life and CorVista Health announced U.S. FDA clearance of the CorVista System with Pulmonary Hypertension (PH) Add-On Module
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FDA Grants HemoSonics Expanded Use of its Bleeding Management System
HemoSonics received Special 510(k) clearance from the U.S. FDA for the expanded use of arterial blood samples with its Quantra QStat Cartridge
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FDA Clears Cardiac Troponin I Test for Myocardial Infarction Diagnosis
The new high-sensitivity troponin assay is designed for use on the the PATHFAST Biomarker Analyzer from Polymedco.
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Blood Test Cuts Diagnosis Time of Nontuberculous Mycobacteria
Researchers developed a platform for diagnosing nontuberculous mycobacteria infections where blood testing can quickly yield results.
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