| 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 |
| 04049016152057 - EUROArray wash buffer set | 2026-02-04 |
| 04049016151814 - ELISA wash buffer 10x conc. | 2026-01-21 |
| 04049016116110 - Anti-Echinococcus EUROLINE WB (IgG) | 2026-01-19 |
| 04049016151951 - Tween 20 (IFA) | 2026-01-14 |
| 04049016151968 - Tween 20 (IFA) | 2026-01-14 |
| 04049016092599 - Anti-Glutamate receptor (type NMDA) IFA | 2025-12-29 |
| 04049016092605 - Anti-Glutamate receptor (type NMDA) IFA | 2025-12-29 |
| 04049016126034 - EUROArrayScan | 2025-12-29 |