Device class
Class II
Regulation 866.5270
Total clearances
3
2022-12-16 → 2026-04-02
Definition
What is Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Classification details
Medical specialty
Immunology
Regulation number
866.5270
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 |
| 86140 |
CPT
|
— |
High
|
C-reactive protein measurement; cardiac risk stratification assay |
Pulse
Most recent 510(k) clearances