| Primary Device ID | 04049016026884 |
| NIH Device Record Key | cfdb13eb-fccf-41e0-b16b-6f59d70aa411 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-dsDNA-NcX ELISA (IgG) |
| Version Model Number | EA 1572-9601 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049016026884 [Primary] |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 04049016151982 - Mounting medium (IIFT) | 2025-07-11 |
| 04049016152002 - Mounting medium (IIFT) | 2025-07-11 |
| 04049016151791 - ELISA sample buffer | 2025-07-10 |
| 04049016151838 - ELISA chromogen/substrate solution | 2025-07-10 |
| 04049016151845 - ELISA Stop solution | 2025-07-04 |
| 04049016137986 - EUROLabWorkstation IFA | 2025-06-30 |
| 04049016140368 - Dehydroepiandrosterone Sulfate (DHEA-S) ELISA | 2025-06-30 |
| 04049016147602 - Free Estriol ELISA | 2025-06-30 |