Device class
—
Regulation —
Total clearances
3
2021-11-29 → 2025-01-10
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Immunexpress, Inc. |
2 |
0 |
2023-12-15 |
|
Inflammatix, Inc. |
1 |
0 |
2025-01-10 |
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 |
| 81519 |
CPT
|
— |
High
|
Quantitative reverse transcription PCR (RT-qPCR) assay for gene expression measurement |
| 81479 |
CPT
|
— |
Medium
|
Unlisted molecular pathology procedure if specific immune biomarker codes unavailable |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2025-01-10 |
K241676 |
Inflammatix, Inc.
|
TriVerity |
| 2023-12-15 |
K232095 |
Immunexpress, Inc.
|
SeptiCyte RAPID |
| 2021-11-29 |
K203748 |
Immunexpress, Inc.
|
SeptiCyte RAPID |