| Primary Device ID | 00816870020518 |
| NIH Device Record Key | 38149745-89a3-4bc5-8f6c-7defd19a2438 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Monobind AccuBind CA 19-9 ELISA Kit - 96 Wells |
| Version Model Number | 3925-300 |
| Catalog Number | 3925-300A |
| Company DUNS | 083155515 |
| Company Name | MONOBIND, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |