| Primary Device ID | 08806141303077 |
| NIH Device Record Key | 11f80303-ec01-4e69-b98f-5bb9637109d8 |
| Commercial Distribution Discontinuation | 2022-10-03 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | One+Step Uric Acid |
| Version Model Number | 31H0P |
| Company DUNS | 688779180 |
| Company Name | DFI 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806141303077 [Primary] |
| KNK | Acid, Uric, Uricase (Colorimetric) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-11 |
| Device Publish Date | 2022-10-03 |
| 08806141303701 - Newfoundland Cholesterol Test | 2024-06-06 |
| 08806141303497 - One+Step 10A | 2023-10-24 One device is included 100 test strips |
| 08806141303480 - One+Step UTI | 2023-10-23 The one device included 100 Strips |
| 08806141301592 - QTEST K | 2022-10-24 100 strips/ 1 bottle |
| 08806141302025 - One+Step Protein | 2022-10-11 100strip/1 bottle |
| 08806141302643 - One+Step pH | 2022-10-11 100strips/ 1 bottle |
| 08806141302650 - One+Step Ketone | 2022-10-11 100strip / 1 bottle |
| 08806141303060 - One+Step Salive & Urine pH | 2022-10-11 100strips/ 1 bottle |