| Primary Device ID | 08059304340215 |
| NIH Device Record Key | 56cef560-0e9c-4232-be16-323a7cb272f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | dIFine ANA HEp-2 Classifier |
| Version Model Number | dIFine ANA HEp-2 Classifier |
| Company DUNS | 441255829 |
| Company Name | VISIA LAB SRL |
| Device Count | 1 |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |