| Primary Device ID | 04049016126034 |
| NIH Device Record Key | f02dcf89-a3ad-49cd-a61b-94cd546716ab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EUROArrayScan |
| Version Model Number | YG 0621-0101 |
| Company DUNS | 322209263 |
| Company Name | EUROIMMUN Medizinische Labordiagnostika AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049016126034 [Primary] |
| NSU | Instrumentation For Clinical Multiplex Test Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-29 |
| Device Publish Date | 2025-12-19 |
| 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 |
| 04049016126034 - EUROArrayScan | 2025-12-29 |
| 04049016152101 - Reagent tray for incubation of slides | 2025-12-05 |
| 04049016152125 - Reagent tray for incubation of slides | 2025-12-05 |
| 04049016139232 - Free Triiodothyronine (FT3) ELISA | 2025-09-22 |
| 04049016151982 - Mounting medium (IIFT) | 2025-07-11 |
| 04049016152002 - Mounting medium (IIFT) | 2025-07-11 |