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Medical Devices / Submissions and Approvals

Aggredyne Cleared for ADP Platelet Test

April 9, 2019
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The FDA granted Aggredyne an additional 510(k) clearance for its ADP assay testing cartridge, used in conjunction with its A-100 platelet analyzing device.

The agency’s clearance widens the menu of tests that can be used with the analyzer, which uses laser light scattering to count platelet aggregates in the sample.

The assays use just a few drops of blood to assess the effect of various antiplatelet drugs that target the platelet P2Y12 receptor.

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