MedTech News

Alamar Biosciences Achieves ISO 13485 Certification, Demonstrating its Commitment to Quality and Safety

FREMONT, Calif., July 25, 2024 /PRNewswire/ — Alamar Biosciences, a company powering precision proteomics to enable the earliest detection of disease, today announces that it has successfully achieved ISO 13485:2016 certification. This internationally recognized standard for quality management systems is specific to the medical devices industry and signifies Alamar Biosciences’ dedication to providing the highest quality products and services to its customers.

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Handheld device offers lab-quality diagnostic testing

Because of its high accuracy, laboratory-based polymerase chain reaction (PCR) testing is the gold standard for infectious disease diagnostics. However, PCR technology requires highly trained staff and costly equipment, hindering its availability, especially in low-resource settings. New research suggests a different kind of test could be more streamlined without sacrificing performance

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