Dimension Vista® System FPSA Flex® Reagent Cartridge K6452
GUDID 00842768016677
Free Prostate Specific Antigen Flex® reagent cartridge 80 Test
Siemens Healthcare Diagnostics Inc.
Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay| Primary Device ID | 00842768016677 |
| NIH Device Record Key | 0510eb5a-af0e-490e-abf6-6f6e9d56d56e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dimension Vista® System FPSA Flex® Reagent Cartridge |
| Version Model Number | 10445091 |
| Catalog Number | K6452 |
| Company DUNS | 005088112 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 2 |
| 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 | true |
| 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(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| Phone | +1(800)441-9250 |
| XX@XX.XX | |
| 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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414601786 [Unit of Use] |
| GS1 | 00842768016677 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P020027
FDA Product Code
| MTG | Test,Prostate Specific Antigen,Free,(Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-02-06 |
| Device Publish Date | 2014-09-24 |
Devices Manufactured by Siemens Healthcare Diagnostics Inc.
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| 00630414317427 - Clinistix UTI Test Strips | 2024-02-29 Test strips for urinary tract infection |
| 00630414626963 - ADVIA Centaur NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ADVIA Centaur - MCM Set |
| 00630414626970 - ATELLICA IM NT-PBNPII (PBNPII) | 2024-02-13 PBNPII - ATELLICA IM - MCM Set |
| 00630414284927 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 100T |
| 00630414284934 - ADVIA Centaur PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - ADVIA Centaur - RGT - 500T |
| 00630414284941 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 100T |
| 00630414284958 - Atellica IM PBNPII | 2024-02-12 NT-proBNPII (PBNPII) - Atellica IM - RGT - 500T |
Trademark Results [Dimension Vista]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DIMENSION VISTA 87350896 5290516 Live/Registered |
Siemens Healthcare Diagnostics Inc. 2017-02-27 |
 DIMENSION VISTA 78480379 3199475 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 2004-09-08 |
 DIMENSION VISTA 76515533 not registered Dead/Abandoned |
Dade Behring Inc. 2003-05-19 |
 DIMENSION VISTA 76511472 3117538 Dead/Cancelled |
Dade Behring Inc. 2003-05-06 |
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