MAUDE manufacturer profile
GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) · PCI
MAUDE profile for Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System
Key facts
| Manufacturer | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) |
|---|---|
| Manufacturer group | GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) |
| Product code | PCI |
| Product code name | Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, False Positive Result, Incorrect, Inadequate or Imprecise Result or Readings, False Negative Result, Missing 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