| Primary Device ID | 04049016027027 |
| NIH Device Record Key | 411ffb57-a2c0-4a8e-b0ee-cccada62fa14 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-Sm ELISA (IgG) |
| Version Model Number | EA 1593-9601 G |
| Company DUNS | 322209263 |
| Company Name | EUROIMMUN Medizinische Labordiagnostika AG |
| 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 | false |