ADVIA Centaur® CA 19-9™ 10491244
GUDID 00630414574028
CA 19-9 - CENTAUR - RGT - 250 tests
Siemens Healthcare Diagnostics Inc.
Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay Cancer antigen 19-9 (CA19-9) IVD, kit, chemiluminescent immunoassay| Primary Device ID | 00630414574028 |
| NIH Device Record Key | e4c8eacd-2063-4eb3-9daf-68b6af2aebac |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ADVIA Centaur® CA 19-9™ |
| Version Model Number | 10491244 |
| Catalog Number | 10491244 |
| 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 |
| 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
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Store Upright, Protect from Light, Do not freeze, Resuspend |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414574028 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K031393
FDA Product Code
| NIG | SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER |
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 | 2019-01-08 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [ADVIA Centaur® CA 19-9™]
| 00630414574257 | CA 19-9 - CENTAUR - RGT - 50 tests |
| 00630414574028 | CA 19-9 - CENTAUR - RGT - 250 tests |
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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