| Primary Device ID | B110AN10160 |
| NIH Device Record Key | c76ec973-0144-42d8-842d-4eeb1da16406 |
| Commercial Distribution Discontinuation | 2017-08-23 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Antinuclear Antibody HEp-2 Antigen Substrate, 16 wells, For IFA Test System |
| Version Model Number | AN-1016 |
| Catalog Number | AN-1016 |
| Company DUNS | 024824641 |
| Company Name | Bion Enterprises, Ltd. |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |