FDA Clears High-Sensitivity Troponin I Assay for Vitros Systems
The quantitative measurement test is designed to aid in myocardial infarction diagnosis using human plasma samples.
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Search Results for: infectious diseases
FDA Clears Four-Plex Respiratory Test for COVID-19, Flu A/B and RSV
Sample-to-answer assay delivers results in approximately 45 minutes from nasopharyngeal and nasal swab specimens.
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AMP Awards Pathologist for Role in Laboratory-Developed Test Litigation
The pathologist served as joint plaintiff in successful lawsuit challenging FDA regulation of LDTs as medical devices.
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EazeBio Partners with UC Santa Cruz to Develop Instrument-Free Diagnostics
The collaboration will focus on creating a cortisol biosensor for stress and metabolic health testing using luminescent biosensors and AI-guided interpretation.
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Co-Diagnostics Develops Sample Prep Instrument for Point-of-Care Tuberculosis Testing
Single-button device designed to streamline workflow for PCR tuberculosis diagnostics in resource-limited settings, with potential deployment across India’s primary health centers.
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