Device To Detect And Identify Selected Microbial Agents That Cause Acute Febrile Illness
The Device to Detect and Identify Selected Microbial Agents that Cause Acute Febrile Illness is an in vitro diagnostic device intended to detect and identify microbial agents in human clinical specimens from patients presenting with signs and symptoms of acute febrile illness who are at risk for or have been exposed to specific pathogens. It is intended as an aid in diagnosis in conjunction with clinical, epidemiologic, and laboratory data including travel history and risk factors. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 866.3966 in the Microbiology specialty. It carries product code QMV and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QMV
- Device Class
- FDA class 2
- Regulation Number
- 866.3966
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243463 | BIOFIRE FILMARRAY Tropical Fever Panel | Dec 05, 2024 | Substantially Equivalent | Biofire Diagnostics, LLC (Biomerieux) |
| K220870 | BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel | Oct 20, 2022 | Substantially Equivalent | Biofire Defense, LLC |
| DEN200043 | FilmArray Global Fever Panel | Nov 20, 2020 | Unknown | Biofire Defense, LLC |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.