Ketostix®
Reagent Strips for Urinalysis: Ketone
17manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Jilin (6), Zhejiang (5), Shandong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Assure Tech. (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 48 |
| Changchun Wancheng BIO-Electron Co., Ltd. | Changchun | Jilin | Contract manufacturer | 34 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Changchun Merydi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| Jilin Hongyi BIO-Tech Co., Ltd. | Changchun | Jilin | Manufacturer | 24 |
| AVE Science & Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Showing 12 of 17. All 17 manufacturers in China registered for Nitroprusside, Ketones (Urinary, Non-Quant.)
Record
| Listed by | Ascensia Diabetes Care US Inc., United States |
|---|---|
| FDA product code | JIN |
| Device type | Nitroprusside, Ketones (Urinary, Non-Quant.) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1435 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2019-06-06 |
| Record revised | 2024-11-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store out of direct sunlight. Replace cap immediately and tightly. Do not remove desiccant from bottle. Read enclosed di; Storage environment temperature 59 to 86 °F |
| Packaging | Carton, shipper/case of 24, shipper/case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2880 | 50 | In distribution | |
| 2881 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mission Urinalysis Reagent Strips | Acon Laboratories, Inc. | 13 |
| Fora | Fora Care Inc. | 10 |
| KetoSens | I-Sens, Inc. | 9 |
| Teco Diagnostics | Teco Diagnostics | 7 |
| Care Touch | Future Diagnostics LLC | 3 |
| STAT-Site WB B-Ketone Test Strips | Stanbio Laboratory, L.P. | 3 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| Precision Xceed Pro | Abbott Diabetes Care Limited | 2 |
| Cardinal Health | Cardinal Health 200, LLC | 2 |
| β-Hydroxybutyrate 21 FS | Diasys Diagnostic Systems Gmbh | 2 |
| D-3 Hydroxybutyrate (Ranbut) | Randox Laboratories Limited | 2 |
| Fisherbrand | Fisher Scientific Company L.L.C. | 2 |
Showing 12 of 62. All products under Nitroprusside, Ketones (Urinary, Non-Quant.)
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.