Carolina Liquid Chemistries Corp.® Uric Acid Reagent KIT AU-212
Uric Acid (URIC) Reagent
6manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
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 | Carolina Liquid Chemistries, 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 |
| Premarket notification | Exempt |
| Record published | 2022-07-06 |
| Record revised | 2023-04-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Sizes | Total volume 15 to 90 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AU-212 | Kit contains 3 R1 bottles | In distribution |
| CC212 | Kit contains 2 cartridges | In distribution |
| BL212 | Total Volume 40 ml | In distribution |
| DT212 | Total Volume 70 ml | In distribution |
| ST212 | Kit contains 3 R1 bottles | 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 |
| 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 |
| ACE | Alfa Wassermann | 2 |
| Atellica CH UA | Siemens Healthcare Diagnostics Inc | 2 |
Showing 12 of 39. All products under Acid, Uric, Uricase (Colorimetric)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K971133 | 1997-04-14 |
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.