| Primary Device ID | 00404847435764 |
| NIH Device Record Key | d690ce84-14b7-4d60-bcda-8fc19d304a4e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-SS-B ELISA |
| Version Model Number | N/A |
| Catalog Number | EIA-3576 |
| Company DUNS | 317134468 |
| Company Name | DRG Instruments Gesellschaft mit beschränkter Haftung |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(973)564-7555 |
| corp@drg-international.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00404847435764 [Primary] |
| LJM | ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-18 |
| Device Publish Date | 2019-06-10 |
| 00404847435764 | Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies ag |
| 04048474035766 | Anti-SS-B ELISA is a test system for the quantitative measurement of IgG class autoantibodies ag |