| Primary Device ID | 06971404131628 |
| NIH Device Record Key | 6196670a-32c7-4f56-8144-7f3dea9fe624 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uric Acid Control solution(level 2) |
| Version Model Number | CM311 |
| Company DUNS | 540481217 |
| Company Name | e-Linkcare Meditech Co., Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06971404131628 [Primary] |
| LFQ | Acid, Uric, Acid Reduction Of Ferric Ion |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-25 |
| Device Publish Date | 2022-05-17 |
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| 06971404131598 - Blood Ketone Control solution(level 2) | 2022-05-25 It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you a |
| 06971404131604 - Blood Ketone Control solution(level 3) | 2022-05-25 It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you a |
| 06971404131611 - Uric Acid Control solution(level 1) | 2022-05-25 It is used to confirm that your Blood Uric Acid Test Strips and Multi-Monitoring Meter are working together properly and that yo |
| 06971404131628 - Uric Acid Control solution(level 2) | 2022-05-25It is used to confirm that your Blood Uric Acid Test Strips and Multi-Monitoring Meter are working together properly and that you are performing the test correctly. |
| 06971404131628 - Uric Acid Control solution(level 2) | 2022-05-25 It is used to confirm that your Blood Uric Acid Test Strips and Multi-Monitoring Meter are working together properly and that yo |
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| 16971404130925 - Blood Uric Acid Monitoring System | 2021-12-27 Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric |
| 26971404130946 - Blood Uric Acid Test Strips | 2021-12-27 Blood uric acid Monitoring Meter with Blood Uric Acid Test Strips are intended for use for the quantitative measurement of uric |