In Vitro Diagnostic EUAs: Overview and Templates
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This table includes information about authorized SARS-CoV-2 diagnostic tests that analyze breath samples and have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and the settings authorized to use the EUA product. Test attributes are listed in the "Attributes" column. For example, tests authorized for the screening of asymptomatic individuals without known exposure are listed with "screening" in the attribute column.
To see additional authorization documents, such as letters granting EUA amendments or revisions, and a list of other brand names authorized under a specific EUA, select the plus (+) button beside the "Date EUA Issued or Last Updated" for each EUA.
Authorized breath tests for the detection of volatile organic compounds associated with SARS-CoV-2 infection are assigned the QSH product code.
|Date EUA Issued or Last Updated||Entity||Diagnostic (Most Recent Letter of Authorization) and Date EUA Originally Issued||Attributes||Authorized Setting(s)1||Authorization Documents2||Other Brand Name(s)|
|04/14/2022||InspectIR Systems LLC||InspectIR COVID-19 Breathalyzer
|Rapid gas chromatography-mass spectrometry (GC-MS), Five Volatile Organic Compounds (VOCs), Screening||Near Patient/Point-of-Care||HCP, Patients, IFU||None|
1 Authorized settings noted as 'Near Patient/Point-of-Care' include environments where the patient specimen is both collected and analyzed and the test is performed by a qualified, trained operator under the supervision of a healthcare provider licensed or authorized by state law to prescribe tests.