MAUDE manufacturer profile
BIOFIRE DIAGNOSTICS, LLC · QOF
MAUDE profile for Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
Key facts
| Manufacturer | BIOFIRE DIAGNOSTICS, LLC |
|---|---|
| Manufacturer group | BIOFIRE DIAGNOSTICS, LLC |
| Product code | QOF |
| Product code name | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
At a glance
- 1–9 MAUDE reports
- 1–9 Injury reports
- 1–9 Problems flagged by Orca1 signal analytics
- Difficult to Open or Remove Packaging Material, Muscle/Tendon Damage, False Negative Result, False Positive Result, Respiratory Failure Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1