| Primary Device ID | 00404847435962 |
| NIH Device Record Key | cde5df97-c30f-4bc0-b478-49219854a84a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | c-ANCA (PR3) ELISA |
| Version Model Number | N/A |
| Catalog Number | EIA-3596 |
| 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 | 00404847435962 [Primary] |
| MOB | TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-13 |
| Device Publish Date | 2019-06-05 |
| 00404847435962 | c-ANCA (PR 3) ELISA is a test system for the quantitative measurement of IgG class autoantibodie |
| 04048474035964 | c-ANCA (PR 3) ELISA is a test system for the quantitative measurement of IgG class autoantibodie |