MAUDE manufacturer profile
ABBOTT IRELAND DIAGNOSTICS DIVISION · MTF
MAUDE profile for Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer
Key facts
| Manufacturer | ABBOTT IRELAND DIAGNOSTICS DIVISION |
|---|---|
| Manufacturer group | ABBOTT IRELAND DIAGNOSTICS DIVISION |
| Product code | MTF |
| Product code name | Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, High Test Results, Low Test Results, No Known Impact Or Consequence To Patient 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