ACE
Uric Acid Reagent
6manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (4), Shandong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Alfa Wassermann, United States |
|---|---|
| FDA product code | KNK |
| Device type | Acid, Uric, Uricase (Colorimetric) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1775 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K113389 |
| Record published | 2017-10-10 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SA1025 | In distribution | |
| RX1025 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 18 |
| JAS Diagnostics | Drew Scientific, Ltd. | 9 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 7 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Carolina Liquid Chemistries Corp.® Uric Acid Reagent KIT AU-212 | Carolina Liquid Chemistries | 5 |
| Uric Acid ver.2 | Roche Diagnostics Gmbh | 4 |
| ONE+Step Uric Acid | DFI Co., Ltd. | 4 |
| AU | Beckman Coulter, Inc. | 4 |
| Pointe Scientific, Inc. Uric Acid | Horiba Instruments Incorporated | 3 |
| Uric Acid (UA) | Randox Laboratories Limited | 3 |
| Teco Diagnostics Uric Acid Liquid Reagent Set | Teco Diagnostics | 3 |
| Atellica CH UA | Siemens Healthcare Diagnostics Inc | 2 |
Showing 12 of 39. All products under Acid, Uric, Uricase (Colorimetric)
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.