| Primary Device ID | 04049016027010 |
| NIH Device Record Key | 6a58857e-e61b-404a-a5d7-dc74b0974a15 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-nRNP/Sm ELISA (IgG) |
| Version Model Number | EA 1591-9601 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 | 04049016027010 [Primary] |
| LKO | Anti-Rnp Antibody, Antigen And 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 |
| 04049016151876 - Sample buffer 2, Crithidia luciliae sensitive (IFA) | 2025-03-14 |
| 04049016151890 - Sample buffer 2, Crithidia luciliae sensitive (IFA) | 2025-03-14 |
| 04049016151920 - PBS-Tween (IFA) | 2025-03-12 |
| 04049016151883 - Sample buffer (IFA) | 2025-03-06 |
| 04049016151906 - Sample buffer (IFA) | 2025-03-06 |
| 04049016151913 - Sample buffer (IFA) | 2025-03-06 |
| 04049016151937 - PBS (IFA) | 2025-03-06 |
| 04049016151944 - PBS (IFA) | 2025-03-06 |