| Primary Device ID | B110ANK600 |
| NIH Device Record Key | 0bbcad75-d043-4d0d-970f-7d0b5246f7bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANA (HEp-2) Test System, 60 Tests |
| Version Model Number | ANK-60 |
| Catalog Number | ANK-60 |
| 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 | false |
| 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 |