Device class
Class II
Regulation 864.7295
Total clearances
3
2020-09-17 → 2024-10-10
Definition
What is Anti-Factor Xa Activity Test System, Apixaban
A heparin and direct oral factor Xa inhibitor drug test system is intended for the detection of heparin and direct oral factor Xa inhibitors in human specimens collected from patients taking heparin or direct oral factor Xa inhibitors. This device is intended to aid in the management of therapy in conjunction with other clinical and laboratory findings.
Classification details
Medical specialty
Hematology
Regulation number
864.7295
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 |
| 85536 |
CPT
|
— |
Medium
|
Heparin activity measurement; covers direct oral Factor Xa inhibitor monitoring |
| 85732 |
CPT
|
— |
Medium
|
Prothrombin time, INR/PT; applicable for anticoagulant management testing including Factor Xa inhibitors |
Pulse
Most recent 510(k) clearances