| Primary Device ID | 00884883005617 |
| NIH Device Record Key | ffdcd91d-37c3-491f-873f-795a95bfd4e8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CEDIA N-Acetylprocainamide Assay |
| Version Model Number | 100015 |
| Company DUNS | 122153799 |
| Company Name | Microgenics Corporation |
| 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 | 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 | false |