Device class
Class II
Regulation 866.5100
Total clearances
4
2023-09-29 → 2026-06-25
Classification details
Medical specialty
Immunology
Regulation number
866.5100
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 |
| 86235 |
CPT
|
— |
High
|
Extractable nuclear antigen (ENA) panel; standard autoimmune serology |
Pulse
Most recent 510(k) clearances