Device class
Class II
Regulation 866.3966
Total clearances
3
2020-11-20 → 2024-12-05
Definition
What is Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
A device to detect and identify selected microbial agents that cause acute febrile illness is identified as a in vitro device intended for the detection and identification of microbial agents in human clinical specimens from patients with signs and symptoms of acute febrile illness who are at risk for exposure or who may have been exposed to these agents. It is intended to aid in the diagnosis of acute febrile illness in conjunction with other clinical, epidemiologic, and laboratory data, including patient travel, pathogen endemicity, or other risk factors.
Classification details
Medical specialty
Microbiology
Regulation number
866.3966
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 |