FDA Announces Final Rule on LDT Regulation
The U.S. FDA finalized a rule regarding its oversight of LDTs to make explicit that IVDs are considered devices under the FD&C Act.
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Search Results for: compliance
Bruker Expands Clinical Microbiology and Infection Diagnostics Portfolio
Bruker enhanced diagnostic solutions in microbial identification, antimicrobial susceptibility testing, early sepsis diagnostics, and more.
Read MoreWebinar: Elevate Trauma Care with Advanced Coagulation Testing
Join our webinar to learn how aligning clinical and laboratory practices using the Quantra Hemostasis System can dramatically improve management of critical bleeding. Gain insights on viscoelastic testing, rapid identification of acute coagulopathy, and effective team collaboration. Perfect for technicians, lab managers, and healthcare providers.
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Researchers Discover Urine-Based Test to Detect Head and Neck Cancer
Researchers developed a urine-based test utilizing whole genome sequencing to detect DNA fragments released by head and neck tumors.
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Babson Diagnostics’ Hand-Warming Device Supports Collection of Capillary Blood Samples
Babson Diagnostics’ new hand-warming technology is designed to support the collection of high-quality blood samples from a fingertip.
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