ADVIA Centaur® Systems iPTH Calibrator 10492394
GUDID 00630414579207
PTH Intact - CENTAUR - CAL - 2x2x1mL
Siemens Healthcare Diagnostics Inc.
Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator Parathyroid hormone (PTH) IVD, calibrator| Primary Device ID | 00630414579207 |
| NIH Device Record Key | 9e7c4b7d-46ef-4c3a-b545-dbe753d876d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADVIA Centaur® Systems iPTH Calibrator |
| Version Model Number | 10492394 |
| Catalog Number | 10492394 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| 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 |
Customer Support Contacts
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| Phone | +1(877)229-3711 |
| XX@XX.XX | |
| 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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -20 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
| Special Storage Condition, Specify | Between 0 and 0 *Store below -20 deg C & Store Upright |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414579207 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K020217
FDA Product Code
| JIT | CALIBRATOR, SECONDARY |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [ADVIA Centaur® Systems iPTH Calibrator]
| 00630414579207 | PTH Intact - CENTAUR - CAL - 2x2x1mL |
| 00630414579191 | PTH Intact - CENTAUR - CAL - 6x2x1mL |
| 00630414472553 | Intact PTH - CENTAUR - CAL - 2x2x1mL |
Trademark Results [ADVIA Centaur]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ADVIA CENTAUR 75658644 2427460 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1999-03-11 |
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