| Primary Device ID | 08806141300755 |
| NIH Device Record Key | 84f4bdfc-af62-48dd-b2f0-2c0994b6e54a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CYBOW 11 |
| Version Model Number | 0A94 |
| Company DUNS | 688779180 |
| Company Name | DFI CO.,LTD |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806141300755 [Primary] |
| GS1 | 08806141300793 [Unit of Use] |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-12-22 |
| Device Publish Date | 2016-10-06 |
| 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 |