| Primary Device ID | 15099590212957 |
| NIH Device Record Key | 60ed7d6b-a28f-4117-a3f7-da1da9c51c9c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Beckmancoulter |
| Version Model Number | IM0645U |
| Catalog Number | IM0645U |
| Company DUNS | 270264732 |
| Company Name | IMMUNOTECH |
| 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 | true |
| 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 | true |
| OTC Over-The-Counter | false |