| Primary Device ID | 00697077002558 |
| NIH Device Record Key | 21d8bb6a-56a6-4401-822b-1dd84c64dd5f |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DS-KR1-CHFH-DAX |
| Company DUNS | 203163290 |
| Company Name | Amico Diagnostic Incorporated |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |