MAUDE manufacturer profile
ANDON MEDICAL CO.,LTD · QKP
MAUDE profile for Coronavirus Antigen Detection Test System.
Key facts
| Manufacturer | ANDON MEDICAL CO.,LTD |
|---|---|
| Manufacturer group | ANDON MEDICAL CO.,LTD |
| Product code | QKP |
| Product code name | Coronavirus Antigen Detection Test System. |
At a glance
- 100–999 MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- False Negative Result, No Clinical Signs, Symptoms or Conditions, Anxiety, No Apparent Adverse Event, False Positive Result, Viral Infection, Product Quality Problem, Insufficient Information 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