MAUDE manufacturer profile
ORASURE TECHNOLOGIES, INC · QKP
MAUDE profile for Coronavirus Antigen Detection Test System.
Key facts
| Manufacturer | ORASURE TECHNOLOGIES, INC |
|---|---|
| Manufacturer group | ORASURE TECHNOLOGIES, INC |
| Product code | QKP |
| Product code name | Coronavirus Antigen Detection Test System. |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Insufficient Information, Viral Infection, Appropriate Term / Code Not Available, Incorrect, Inadequate or Imprecise Result or Readings, False Negative Result, Pain, Headache 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