MAUDE manufacturer profile
T2 BIOSYSTEMS, INC · QJR
MAUDE profile for Reagents, 2019-Novel Coronavirus Nucleic Acid
Key facts
| Manufacturer | T2 BIOSYSTEMS, INC |
|---|---|
| Manufacturer group | T2 BIOSYSTEMS, INC |
| Product code | QJR |
| Product code name | Reagents, 2019-Novel Coronavirus Nucleic Acid |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 1–9 Problems flagged by Orca1 signal analytics
- False Negative Result, False Positive Result, Insufficient Information, No Clinical Signs, Symptoms or Conditions, Viral Infection, Adverse Event Without Identified Device or Use 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