Pointe Scientific, Inc.
Uric Acid Standard intended for use as an uric acid standard for standardization or calibration of uricase / trinder uric acid procedures. Packaged at 1 x 15ml
6manufacturers in China registered for this device type
7catalogue numbers in this listing
3recalls on this 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 | Horiba Instruments Incorporated, 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) | K970560 |
| Record published | 2016-08-31 |
| Record revised | 2025-10-02 (version 4) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 13-U7581-500 | In distribution | |
| U7581-1L | In distribution | |
| U7581-500 | In distribution | |
| 13-U7581-120 | In distribution | |
| HU982-615 | In distribution | |
| U7581-120 | In distribution | |
| U7580-STD | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 18 |
| JAS Diagnostics | Drew Scientific, Ltd. | 9 |
| 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 |
| Atellica CH UA | Siemens Healthcare Diagnostics Inc | 2 |
Showing 12 of 39. All products under Acid, Uric, Uricase (Colorimetric)
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Horiba Instruments Incorporated | 510(k) number | 2009-12-01 | Not classified | Device Design | A process deviation occurred during the production of the R1 component which may affect its performance. | 12 kits | 2010-10-08 |
| Horiba Instruments Incorporated | 510(k) number | 2009-12-01 | Not classified | Device Design | A process deviation occurred during the production of the R1 component which may affect its performance. | 1 kit | 2010-10-08 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2016-01-11 | Class II | Under Investigation by firm | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantipyrine and phenol, and can produce falsely low results with t | 216 | 2016-06-07 |
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.