Device class
Class II
Regulation 866.3983
Total clearances
5
2023-05-05 → 2026-04-13
Definition
What is Sars-Cov-2 Serology Test
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.
Classification details
Medical specialty
Microbiology
Regulation number
866.3983
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| 86769 |
CPT
|
— |
High
|
Antibody serology test for SARS-CoV-2; standard code for COVID-19 antibody detection |
Pulse
Most recent 510(k) clearances