FDA product code PTC
Uric Acid Test System For At Home Prescription Use
Clinical Chemistry·Class 1·21 CFR 862.1775
US regulatory classifications
- US Product Code (FDA)
- PTCView Product Code Classification →
- US Risk Class (FDA)
- Class 1
- US Regulation (CFR)
- 21 CFR 862.1775View CFR Regulation →
- Medical specialty
- Clinical Chemistry
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
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About this record
Uric Acid Test System For At Home Prescription Use is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.