Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Uric Acid Test System For At Home Prescription Use

FDA product code PTC · 3 cleared devices

Class 1 Clinical Chemistry
Regulation
21 CFR 862.1775
Review panel
CH
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2017-04-11 – 2025-04-04

For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.

↑