MAUDE manufacturer profile
QUIDEL CORPORATION · QKP
MAUDE profile for Coronavirus Antigen Detection Test System.
Key facts
| Manufacturer | QUIDEL CORPORATION |
|---|---|
| Manufacturer group | QUIDEL CORPORATION |
| Product code | QKP |
| Product code name | Coronavirus Antigen Detection Test System. |
At a glance
- 1,000+ MAUDE reports
- 10–99 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, No Apparent Adverse Event, False Positive Result, Insufficient Information, False Negative Result, Erratic Results, Incorrect, Inadequate or Imprecise Result or Readings, Device Markings/Labelling Problem 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