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Tag Archive: 510(k)

Dear Stanley: Assayed vs Unassayed Molecular Controls

Stanley Staphylococcus October 18, 2018 5 Comments

Dear Stanley, I’m completely confused about the terms “assayed” and “unassayed” in relation to controls for molecular diagnostic instruments. Does “unassayed” mean the manufacturer of the control hasn’t tested the products? Can you shed some light on what these terms…
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510(k), assay, FDA, medical device, molecular diagnostics

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