MAUDE manufacturer profile
ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG · QUM
MAUDE profile for Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test
Key facts
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG |
|---|---|
| Manufacturer group | ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG |
| Product code | QUM |
| Product code name | Human Immunodeficiency Virus (Hiv) Viral Load Monitoring Test |
At a glance
- 1–9 MAUDE reports
- 1–9 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Low Test Results, False Positive Result, High Test Results 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