| Primary Device ID | 04049016027201 |
| NIH Device Record Key | bb5b156a-c496-4e0a-9b9f-7d3a9f4fd233 |
| Commercial Distribution Discontinuation | 2017-09-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Anti-ß2-Glycoprotein 1 ELISA (IgM) |
| Version Model Number | EA 1632-9601 M |
| Company DUNS | 322209263 |
| Company Name | EUROIMMUN Medizinische Labordiagnostika AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |