Device class
—
Regulation —
Total clearances
3
2020-11-20 → 2024-12-05
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
| Sponsor |
Clearances |
Last 12 mo |
Most recent |
|
Biofire Defense, LLC
|
2 |
0 |
2022-10-20 |
|
Biofire Diagnostics, LLC (Biomerieux) |
1 |
0 |
2024-12-05 |
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 |
| 87623 |
CPT
|
— |
Medium
|
Nucleic acid probe, each organism; respiratory virus (includes influenza, parainfluenza, respiratory syncytial virus, coronavirus, and rhinovirus) |
| 87798 |
CPT
|
— |
Medium
|
Comprehensive screening panel or qualitative identification by nucleic acid amplification methods |
Pulse
Most recent 510(k) clearances
| Date | K-number | Sponsor | Device |
|---|
| 2024-12-05 |
K243463 |
Biofire Diagnostics, LLC (Biomerieux)
|
BIOFIRE FILMARRAY Tropical Fever Panel |
| 2022-10-20 |
K220870 |
Biofire Defense, LLC
|
BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel |
| 2020-11-20 |
DEN200043 |
Biofire Defense, LLC
|
FilmArray Global Fever Panel |