Architect
Catalogue number 3P39-21, listed by Abbott Laboratories, United States, under Acid, Uric, Uricase (Colorimetric). 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
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 | Abbott Laboratories, United States |
|---|---|
| FDA product code | KNK |
| Device type | Acid, Uric, Uricase (Colorimetric) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1775 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-07-31 |
| Record revised | 2024-02-21 (version 3) |
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; Handling environment temperature up to 29 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3P39-21 | 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 |
| ACE | Alfa Wassermann | 2 |
Showing 12 of 39. All products under Acid, Uric, Uricase (Colorimetric)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K102568 | 2011-05-06 |
| K896954 | 1990-02-23 |
| K844011 | 1984-10-30 |
| K841702 | 1984-05-31 |
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.