Uric Acid Test System For At Home Prescription Use
Clinical Chemistry · 21 CFR 862.1775
For the quantitative measurement of uric acid in home use settings by patients diagnosed with gout. This device is for prescription use only.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
2 recall events for this product code
- Visgeneer, Inc.Open, ClassifiedSep 2, 2025
Blood Uric Acid Monitoring System
Due to products distributed without premarket clearance or approvals.
Z-2500-2025 · View FDA record ↗ - Visgeneer, Inc.Open, ClassifiedSep 2, 2025
Blood Uric Acid Monitoring System
Due to products distributed without premarket clearance or approvals.
Z-2501-2025 · View FDA record ↗
Registered firms
5 firms currently registered for this product code
510(k) clearances
3 clearances for this product code
- Apex BioTechnology Corp.Apr 4, 2025
K242209 · UASure II Blood Uric Acid Monitoring System
- Taidoc Technology CorporationDec 10, 2018
K181675 · FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System
- Nova Biomedical CorporationApr 11, 2017
K160990 · Nova Max Uric Acid Monitoring System