MAUDE manufacturer profile
ACON LABORATORIES, INC. · QKP
MAUDE profile for Coronavirus Antigen Detection Test System.
Key facts
| Manufacturer | ACON LABORATORIES, INC. |
|---|---|
| Manufacturer group | ACON LABORATORIES, INC. |
| 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
- Insufficient Information, Unable to Obtain Readings, False Negative Result, False Positive Result, No Clinical Signs, Symptoms or Conditions, No Device Output, Incorrect, Inadequate or Imprecise Result or Readings, Nonstandard Device 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