| Primary Device ID | 00887473000139 |
| NIH Device Record Key | 8b1424e1-98c5-43a4-913e-3e87ce3004f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SD Glucose Control Solution |
| Version Model Number | 01GCS10 |
| Company DUNS | 557812789 |
| Company Name | SD Biosensor, Inc. |
| 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 | true |
| 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 | false |
| OTC Over-The-Counter | true |