| Primary Device ID | 08806141304043 |
| NIH Device Record Key | 9b492293-e65c-494f-bd6b-02fd0c474fbf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ONE+Step Uric Acid |
| Version Model Number | 31H7 |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 30 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806141304043 [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 | 2025-09-12 |
| Device Publish Date | 2025-09-04 |
| 08806141303077 | 31H0P |
| 08806141304029 | The one device that has DI number included 5 strips |
| 08806141304036 | One pack included 10 pouch |
| 08806141304043 | One packing included 5 pouch. |