| Primary Device ID | 00630414608761 |
| NIH Device Record Key | 71d4a2e9-059a-4c4a-879c-3cfc265ec99b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Atellica IM aTPOII |
| Version Model Number | 11206077 |
| Catalog Number | 11206077 |
| Company DUNS | 296822794 |
| Company Name | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 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 | false |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerated, store upright, do not resuspend, keep away from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414608761 [Primary] |
| JZO | SYSTEM, TEST, THYROID AUTOANTIBODY |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-03 |
| Device Publish Date | 2026-01-26 |
| 00630414608761 | Anti-Thyroid Peroxidase II (aTPOII) Atellica IM - RGT 500T |
| 00630414608754 | Anti-Thyroid Peroxidase II (aTPOII) Atellica IM - RGT 100T |