MAUDE manufacturer profile
TOSOH HI-TEC, INC. · PDJ
MAUDE profile for Hemoglobin A1c Test System
Key facts
| Manufacturer | TOSOH HI-TEC, INC. |
|---|---|
| Manufacturer group | TOSOH HI-TEC, INC. |
| Product code | PDJ |
| Product code name | Hemoglobin A1c Test System |
At a glance
- 10–99 MAUDE reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Incorrect, Inadequate or Imprecise Result or Readings, Smoking, Noise, Audible, High Readings, Device Ingredient or Reagent Problem, Fire, Sparking 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