Device class
Class II
Regulation 866.3215
Total clearances
4
2021-09-01 → 2023-06-30
Definition
What is Immunoassay For Host Biomarkers Of Infection
A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens.
Classification details
Medical specialty
Microbiology
Regulation number
866.3215
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 |
| 86003 |
CPT
|
— |
High
|
Allergen specific IgE quantitative or semiquantitative, each allergen; standard immunoassay panel code applicable to host biomarker testing |
| 86769 |
CPT
|
— |
Medium
|
Antibody; infectious agent analyte; immunoassay for infection biomarkers |
Pulse
Most recent 510(k) clearances