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  7. In Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients
  1. Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices

In Vitro Diagnostics EUAs - IVDs for Management of COVID-19 Patients

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)
07/22/2021 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 None None
06/02/2020 Roche Diagnostics Elecsys IL-6
06/02/2020
Immunoassay-IL-6 H, M HCP, Patients, IFU None None
10/01/2020 Beckman Coulter, Inc. Access IL-6
10/01/2020
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
12/18/2020
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.

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