| Primary Device ID | 04049016151562 |
| NIH Device Record Key | 0763a1fb-6f9a-4219-a396-fc796d76c0e5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ELISA enzyme conjugate, anti-human IgA |
| Version Model Number | AE 121-1012 |
| 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 | 04049016151562 [Primary] |
| PPM | General Purpose Reagent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-18 |
| Device Publish Date | 2024-11-08 |
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| 04049016151227 - FITC-labelled anti-human IgA | 2024-11-18 |
| 04049016151234 - FITC-labelled anti-human IgG | 2024-11-18 |
| 04049016151562 - ELISA enzyme conjugate, anti-human IgA | 2024-11-18 |
| 04049016151562 - ELISA enzyme conjugate, anti-human IgA | 2024-11-18 |
| 04049016151593 - FITC-labelled anti-human IgA | 2024-11-18 |
| 04049016151609 - FITC-labelled anti-human IgG | 2024-11-18 |
| 04049016137894 - IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern | 2024-09-19 |
| 04049016151999 - Mounting medium (IFA) | 2024-07-25 |