MAUDE manufacturer profile
LUCIRA HEALTH, INC. · QJR
MAUDE profile for Reagents, 2019-Novel Coronavirus Nucleic Acid
Key facts
| Manufacturer | LUCIRA HEALTH, INC. |
|---|---|
| Manufacturer group | LUCIRA HEALTH, INC. |
| Product code | QJR |
| Product code name | Reagents, 2019-Novel Coronavirus Nucleic Acid |
At a glance
- 1,000+ MAUDE reports
- 1–9 Injury reports
- 1,000+ Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- False Positive Result, No Clinical Signs, Symptoms or Conditions, Insufficient Information, False Negative Result, Incorrect, Inadequate or Imprecise Result or Readings, Product Quality Problem, Pain, Output Problem 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