Device class
Class II
Regulation 866.3984
Total clearances
3
2023-06-06 → 2026-08-07
Definition
What is Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.
Classification details
Medical specialty
Microbiology
Regulation number
866.3984
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Cue Health, Inc.
|
2 |
0 |
2023-11-28 |
|
Aptitude Medical Systems, Inc. |
1 |
1 |
2026-08-07 |
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 |
| 87426 |
CPT
|
— |
High
|
SARS-CoV-2 molecular test; OTC home-use nucleic acid detection for COVID-19 |
Pulse
Most recent 510(k) clearances