HEALTH AND HUMAN SERVICES, DEPARTMENT OF / OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE / ASPR OFFICE OF THE ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE / OFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSE

Advancement of Ortho Clinical Diagnostics VITROS Immunodiagnostic Products Assay for the Detection of SARSCoV-2 Antigen through De Novo 510k Submission

75A50121P00041ContractAward NoticeSAM.gov

Quick Facts

NAICS

541715

Set-Aside

Full & Open

Place of Performance

Raritan, NJ

Description

This justification for unusual and compelling urgency is due to the public health emergency caused by COVID-19, which was declared a global pandemic by the WHO. The first confirmed case of COVID-19 in the United States was announced on January 21, 2020 and a national emergency was declared via Presidential Proclamation on March 13, 2020. The ultimate spread, length of time, and severity of the COVID-19 outbreak is unknown as this time and current data indicate that COVID-19 has begun to spread exponentially, in the typical pattern for an epidemic. The goal of the ongoing U.S. public health response is to respond to and mitigate sustained spread of COVID-19 in this country.