| Primary Device ID | B110RGM7613D0 |
| NIH Device Record Key | 8f8eb0db-2f32-4bcb-9f5a-a0eb52b8415b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BP 230 ELISA TEST |
| Version Model Number | RG-M7613-D |
| Catalog Number | RG-M7613-D |
| 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 | true |
| 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 |