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Similarly, over-the-counter tests to detect SARS-CoV-2, diabetes digital behavioral therapeutic devices, prognostic tests to assess chronic kidney disease progression, non-medicated topical formulations to treat erectile dysfunction, and active noise attenuation systems for infant incubators were also classified as class II devices with special controls

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Bartels GL, Remme WJ, Holwerda KJ, Kruijssen DA

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