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or Canada, so its sold through a gray market labeling loophole

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Dosage and Administration: For Parenteral Use Only after dilution or dissolution of compatible drugs, following manufacturer instructions: Do Not Use Directly : Not suitable for direct IV, IM, or SC injection without first being mixed with a solute

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The commenter noted that their company is not operating as an Independent Diagnostic Testing Facility (IDTF) but rather entering into contractual agreements with facilities to offer e-Lung as a software-as-a-medical-device (SaMD) for which the hospitals will then submit claims as the provider