Device class
Class II
Regulation 866.6010
Total clearances
4
2020-02-13 → 2024-05-09
Classification details
Medical specialty
Immunology
Regulation number
866.6010
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 |
| 86000 |
CPT
|
— |
Medium
|
Agglutination test; blood grouping, serologic |
| 86305 |
CPT
|
— |
Medium
|
Immunoassay or other multiplex assay, tumor antigen (e.g., CA 15-3, CA 19-9) |
Pulse
Most recent 510(k) clearances