| Primary Device ID | 04049016148265 |
| NIH Device Record Key | 4d1bce1e-6376-45b6-ad7e-60ca0f3bb80d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EUROArrayProcessor reagent tray set |
| Version Model Number | ZM 9999-0640-5 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049016148265 [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 | 2023-03-13 |
| Device Publish Date | 2023-03-03 |
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| 04049016069355 - Adjustment solution | 2023-06-02 |
| 04049016151821 - Adjustment solution | 2023-06-02 |
| 04049016137740 - Free Testosterone ELISA | 2023-05-03 |
| 04049016140085 - Total Testosterone ELISA | 2023-05-03 |