MAUDE manufacturer profile
BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. · QKP
MAUDE profile for Coronavirus Antigen Detection Test System.
Key facts
| Manufacturer | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
|---|---|
| Manufacturer group | BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. |
| Product code | QKP |
| Product code name | Coronavirus Antigen Detection Test System. |
At a glance
- 1,000+ MAUDE reports
- 1–9 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, No Consequences Or Impact To Patient, False Positive Result, False Negative Result, No Information, Device Markings/Labelling Problem, No Patient Involvement 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