| Primary Device ID | 03701700800095 |
| NIH Device Record Key | ba36b397-2496-4677-840f-7a3ce8022985 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ENVOY 500 SERUM CALIBRATOR KIT |
| Version Model Number | 55111 |
| Company DUNS | 267732378 |
| Company Name | VITALSCIENTIFIC |
| 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 |