Product code PTC
- Device name
- Uric Acid Test System For At Home Prescription Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1775
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Definition
- For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
- Source
- FDA openFDA device classification dataset