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Devices & Diagnostics Letter
Nov. 12, 2012 | Vol. 39 No. 45
Guidance Asks for Tests to Establish Validity of Highly Multiplexed IVDs
Clinical validation of highly multiplexed microbiological/medical countermeasure in vitro nucleic acid-based diagnostic devices (HMMDs) should include a limited prospective, randomized study of patients with symptoms of the infection the device is intended to identify.
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