Device class
Class II
Regulation 866.3981
Total clearances
11
2021-11-01 → 2025-02-13
Definition
What is Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
Classification details
Medical specialty
Microbiology
Regulation number
866.3981
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
|
COVID-19 antibody/antigen detection; SARS-CoV-2 detection |
| 87426 |
CPT
|
— |
High
|
Influenza virus nucleic acid detection by NAATs; covers respiratory specimen nucleic acid testing |
| 87635 |
CPT
|
— |
High
|
Respiratory syncytial virus (RSV) nucleic acid detection; covers respiratory specimen nucleic acid testing |
Pulse
Most recent 510(k) clearances