Precision Xtra
Precision Xtra Blood ß-Ketone Test Strips
17manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
1recall
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 | Abbott Diabetes Care Limited, United Kingdom |
|---|---|
| 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 |
| 510(k) | K060768 |
| Record published | 2016-07-22 |
| Record revised | 2023-10-18 (version 7) |
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 | Storage environment temperature 39 to 86 °F |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70745 | 10 | In distribution | |
| 70746 | 10 | 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 |
| Ketostix® | Ascensia Diabetes Care US Inc. | 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 |
Showing 12 of 62. All products under Nitroprusside, Ketones (Urinary, Non-Quant.)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K060768 | 2006-04-21 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| Abbott Diabetes Care Limited | 510(k) number | 2019-11-14 | Class II | Labeling False and Misleading | Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to | 2021-04-28 |
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.