In Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients
In Vitro Diagnostic EUAs: Overview and Templates
This table includes information about authorized in vitro diagnostic devices 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 devices with certain conditions of authorization required of the manufacturer and authorized laboratories.
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 IL-6 Diagnostic Tests are assigned the QLC product code. Authorized sodium citrate blood specimen collection tubes are assigned the QPW 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 Documents||Other Brand Name(s)|
|08/18/2021||Becton, Dickinson and Company||BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing Site) 07/22/2021||Blood Collection Tube||H,M||HCP and Authorized Laboratories, IFU||None||None|
|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|
1 Authorized 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.