MAUDE manufacturer profile
GENMARK DIAGNOSTICS · QJR
MAUDE profile for Reagents, 2019-Novel Coronavirus Nucleic Acid
Key facts
| Manufacturer | GENMARK DIAGNOSTICS |
|---|---|
| Manufacturer group | GENMARK DIAGNOSTICS |
| Product code | QJR |
| Product code name | Reagents, 2019-Novel Coronavirus Nucleic Acid |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, False Negative Result, False Positive Result, Insufficient Information, Viral Infection, Non Reproducible Results, Signal Artifact/Noise, Incorrect, Inadequate or Imprecise Result or Readings 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