Advancement of Ortho Clinical Diagnostics VITROS Immunodiagnostic Products Assay for the Detection of SARSCoV-2 Antigen through De Novo 510k Submission
Award Notice Posted
- Solicitation number
- 75A50121P00041
- Agency
-
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
- Awarded
- to Ortho-Clinical Diagnostics, Inc.
- Set-aside
- No set-aside
Opportunity facts
- Contract number
- 75A50121P00041 Federal contract award
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Raritan NJ 08869 USA
Notice details come from SAM.gov. Updated .
About this opportunity
This Award Notice from the Department of Health and Human Services provides Ortho-Clinical Diagnostics, Inc. a contract valued at $3,640,000 to advance their VITROS Immunodiagnostic Products Assay for the detection of SARS-CoV-2 antigen through a de novo 510k submission process. The contract award supports Ortho-Clinical Diagnostics' efforts to obtain FDA clearance for their COVID-19 antigen test through the FDA's premarket notification pathway in response to the ongoing public health emergency caused by the COVID-19 pandemic.
Notice text
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.
Awarded contract 75A50121P00041 to ORTHO-CLINICAL DIAGNOSTICS, INC. for 3640000.00 on 2021-04-16.
Files
| File | Type | Posted |
|---|---|---|
| Class J and A Final 3.21.20.pdf |
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