| Primary Device ID | 00811403011735 |
| NIH Device Record Key | 44846f5a-c2b3-4f3a-81b8-5cb0f2beb3a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ISE Wash Solution Kit |
| Version Model Number | BT-6620940SD |
| Company DUNS | 947514303 |
| Company Name | Diamond Diagnostics 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 | 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 |