| Primary Device ID | B110AND1800I0 |
| NIH Device Record Key | 76c7fa5a-e63d-433f-aa62-fc38aa7bc175 |
| Commercial Distribution Discontinuation | 2019-09-27 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | ANA (HEp-2) Test System, 1800 Tests |
| Version Model Number | AND-1800 I |
| Catalog Number | AND-1800 I |
| 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 |