Eburicacid
blood uric acid monitoring system contains meter 1pcs, test strip 25pcs, lancing device 1pcs and lancet 25pcs
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Guangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
Record
| Listed by | Visgeneer, Inc., Taiwan |
|---|---|
| FDA product code | JHC |
| Device type | Acid, Uric, Uricase (Oxygen Rate) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1775 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-07-05 |
| Record revised | 2025-02-13 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2024-01-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| eBuricacid | Withdrawn | |
| eB-U01 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Uric Acid Test Strip | Urit Medical Electronic Co., Ltd. | 4 |
| Uric Acid Meter | Urit Medical Electronic Co., Ltd. | 2 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Visgeneer, Inc. | UDI-DI | 2023-10-04 | Class II | No Marketing Application | Due to products distributed without premarket clearance or approvals. | 2240 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.