| Primary Device ID | 00886338000031 |
| NIH Device Record Key | 5fe440e6-f316-4a53-9054-9054c3c1946d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | UASure II Blood Uric Acid Monitoring System |
| Version Model Number | S95046 |
| Catalog Number | S95046 |
| Company DUNS | 657608092 |
| Company Name | APEX BIOTECHNOLOGY CORP. |
| 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 | true |
| Device Combination Product | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00886338000031 [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 | 2022-01-04 |
| Device Publish Date | 2021-12-27 |
| 00886338000031 - UASure II Blood Uric Acid Monitoring System | 2022-01-04Complete Kit |
| 00886338000031 - UASure II Blood Uric Acid Monitoring System | 2022-01-04 Complete Kit |
| 00886338000062 - UASure II Blood Uric Acid Test Strips 25s | 2022-01-04 25s foil packet |
| 00886338000055 - UASure II Uric Acid Control Solution L1 | 2022-01-04 Level 1 |
| 04713648766530 - THE EDGE Blood Lactate Monitoring System | 2021-01-26 KIT |
| 04713648766547 - THE EDGE Blood Lactate Test Strip (non-sterile) | 2021-01-26 25s |
| 04713648766554 - THE EDGE Lactate Control Solution | 2021-01-26 |
| 04713648766493 - ApexBio SteriLance BLOOD LANCET (Sterile) | 2020-05-25 |
| 04713648766462 - UASure Blood Uric Acid Monitoring Meter | 2020-05-19 Kit (5s) |