Device class
Class II
Regulation 864.5430
Total clearances
7
2020-08-21 → 2025-08-25
Definition
What is Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
A coagulation system for the measurement of whole blood viscoelastic properties is an in vitro diagnostic device used to evaluate blood coagulation, fibrinolysis, or both, in patients.
Classification details
Medical specialty
Hematology
Regulation number
864.5430
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 |
| 85400 |
CPT
|
— |
High
|
Viscoelastic coagulation assessment (ROTEM/TEG-type analyzer) |
Pulse
Most recent 510(k) clearances