MAUDE manufacturer profile
GENMARK DIAGNOSTICS, INC. · OCC
MAUDE profile for Respiratory Virus Panel Nucleic Acid Assay System
Key facts
| Manufacturer | GENMARK DIAGNOSTICS, INC. |
|---|---|
| Manufacturer group | GENMARK DIAGNOSTICS, INC. |
| Product code | OCC |
| Product code name | Respiratory Virus Panel Nucleic Acid Assay System |
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- False Negative Result, No Clinical Signs, Symptoms or Conditions 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