| Primary Device ID | 00630414295039 |
| NIH Device Record Key | 48cd3eb5-6eb7-48ca-a422-9ddca0b2199d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DM EXL LOCI BRAHMS PCT Cal Kit |
| Version Model Number | 11354448 |
| Catalog Number | RC648 |
| Company DUNS | 005088112 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 2 |
| 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 | 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(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)441-9250 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Storage Environment Temperature | Between -25 Degrees Celsius and -15 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414238708 [Primary] |
| GS1 | 00630414295039 [Unit of Use] |
| JIT | Calibrator, secondary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-11-23 |
| Device Publish Date | 2022-11-15 |
| 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 |
| 00630414624518 - Atellica IM TSH3-Ultra II | 2024-05-30 TSH3-ULII Atellica IM - RGT 110T |
| 00630414624525 - Atellica IM TSH3-Ultra II | 2024-05-30 TSH3-ULII Atellica IM – RGT 550T |
| 00630414624532 - Atellica IM TSH3ULII MCM set | 2024-05-30 TSH3-ULII Atellica IM - Consumable MCM Set |
| 00630414624693 - Atellica IM TSH3-Ultra II | 2024-05-30 TSH3-ULII Atellica IM - RGT (REF) 2750T |
| 00630414624709 - ADVIA Centaur TSH3ULII MCM SET | 2024-05-30 TSH3-ULII ADVIA Centaur - Consumable MCM Set |