| Primary Device ID | 00630414306179 |
| NIH Device Record Key | c69c2167-a42c-4a9c-b5e8-5c7d607fd929 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ATELLICA HA1C_E HIGH VOLUME CONVERSION KIT |
| Version Model Number | 11470732 |
| Catalog Number | 11470732 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| 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 | 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 |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| 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 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Special Storage Condition, Specify | Between 0 and 0 *without restriction |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414306179 [Primary] |
| JJE | ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-27 |
| Device Publish Date | 2022-05-19 |
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| 00630414313436 - Atellica CH Diazo Total Bilirubin (D_TBil) | 2024-10-24 Atellica CH Diazo Total Bilirubin (D_TBil) |
| 00630414317472 - Atellica Connect | 2024-09-19 |
| 00630414317489 - Atellica Connect SE | 2024-09-19 |
| 00630414317496 - Atellica Connect Test System | 2024-09-19 |
| 00630414305028 - Atellica CH High Sensitivity C-Reactive Protein 2 (hCRP2) | 2024-06-19 Atellica CH High Sensitivity C-Reactive Protein (hCRP2) Reagent |
| 00630414624488 - ADVIA Centaur TSH3-Ultra II | 2024-05-30 TSH3-ULII ADVIA Centaur - RGT 500T |
| 00630414624501 - ADVIA Centaur TSH3-Ultra II | 2024-05-30 TSH3-ULII ADVIA Centaur - RGT (REF) 2500T |