| Primary Device ID | 04049016027287 |
| NIH Device Record Key | 5724d818-3dcd-4d77-86c4-d064c630d6c3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Anti-tissue Transglutaminase ELISA (IgA) |
| Version Model Number | EA 1910-9601 A |
| Company DUNS | 322209263 |
| Company Name | EUROIMMUN Medizinische Labordiagnostika AG |
| 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 | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04049016027287 [Primary] |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-14 |
| Device Publish Date | 2019-03-06 |
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