510(k) DEN210040
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- May 5, 2023
- Date Received
- September 21, 2021
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sars-Cov-2 Serology Test
- Device Class
- Class II
- Regulation Number
- 866.3983
- Review Panel
- MI
- Submission Type
A SARS-CoV-2 serology test is a prescription in vitro diagnostic device for the detection of specific binding antibodies to SARS-CoV-2 in clinical specimens. The detection of SARS-CoV-2 antibodies is intended to aid in identifying individuals with an adaptive immune response to SARS-CoV-2. The test is not intended for the diagnosis of acute SARS-CoV-2 infection, nor screening blood, plasma, cells, or tissue donors.