In Vitro Diagnostic EUAs: Overview and Templates
This table includes information about authorized in vitro diagnostic tests that may be used in the management of patients with COVID-19 that have been authorized individually. These EUAs have been issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories.
|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 Documents||Other Brand Name(s)|
|06/02/2020||Roche Diagnostics||Elecsys IL-6
|Immunoassay-IL-6||H, M||HCP, Patients, IFU||None||None|
|10/01/2020||Beckman Coulter, Inc.||Access IL-6
|One-step immunoenzymatic ("sandwich") assay, IL-6||H, M||HCP, Patients, IFU||None||None|
|12/18/2020||Siemens Healthcare Diagnostics Inc.||ADVIA Centaur IL6 assay
|One-step Direct Chemiluminescent Immunoassay||H, M||HCP, Patients, IFU||None||None|
- 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.