ReliOn Ultima
Relion Utlima Blood Glucose Monitoring System
12manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jilin (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 | |
| Sejoy Biomedical Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 5 |
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
| Changsha Sinocare Inc. | Changsha | Hunan | Manufacturer | 2 |
Record
| Listed by | Wal Mart Stores, Inc |
|---|---|
| FDA product code | JJX |
| Device type | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| 510(k) | K083223 |
| Record published | 2016-09-16 |
| Record revised | 2023-10-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature -13 to 131 °F |
| Packaging | Case of 4, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 70055 | In distribution | ||
| 70973 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 55 |
| Validate | LGC Clinical Diagnostics, Inc. | 37 |
| Architect | Abbott Laboratories | 24 |
| Architect | Abbott Medical | 23 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 22 |
| Architect | Abbott Ireland | 18 |
| Liquichek | Bio-Rad Laboratories Inc. | 17 |
| Alinity | Abbott Medical | 17 |
| Alinity | Abbott Ireland | 15 |
| Fora | Fora Care Inc. | 15 |
| Pregnancy-Skreen | Biochemical Diagnostics, Inc. | 14 |
| Accurun® | LGC Clinical Diagnostics, Inc. | 14 |
Showing 12 of 907. All products under Single (Specified) Analyte Controls (Assayed And Unassayed)
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 | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Abbott Diabetes Care Limited | 510(k) number | 2010-12-22 | Not classified | Process control | Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results. | 359 total lots, 1,000,000 strips per lot | 2011-10-25 |
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.