U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Medical Devices
  3. Medical Device Safety
  4. Emergency Situations (Medical Devices)
  5. Emergency Use Authorizations for Medical Devices
  6. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
  7. In Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics EUAs - Other Tests for SARS-CoV-2

In Vitro Diagnostic EUAs: Overview and Templates

On This Page:

Individual EUAs for Diagnostic Breath Tests for SARS-CoV-2

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
04/14/2022		 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.

2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.

Individual EUAs for Genotyping Tests for SARS-CoV-2

This table includes information about authorized SARS-CoV-2 genotyping tests that have been authorized for the identification and differentiation of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak (PANGO) lineages. These EUAs have been issued for each individual test with certain conditions of authorization, including those required of the manufacturer, and the settings authorized to use the EUA product. Test attributes are listed in the "Attributes" 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 SARS-CoV-2 genotyping tests are assigned the QTA 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)
06/10/2022 Laboratory Corporation of America (Labcorp) Labcorp VirSeq SARS-CoV-2 NGS Test
06/10/2022		 Next Generation Sequencing (NGS), PANGO lineage H HCP, Patients, EUA Summary None

1Authorized settings include the following:

  • H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
  • M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
  • W - Patient care settings operating under a CLIA Certificate of Waiver.

2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.

Back to Top