Dimension Vista® System PSA CAL KC602

GUDID 00842768024214

Prostate Specific Antigen Calibrator

Siemens Healthcare Diagnostics Inc.

Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple clinical chemistry analyte IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator Multiple-type clinical chemistry analyte profile IVD, calibrator

• Primary Device ID: 00842768024214
• NIH Device Record Key: 77cb8482-1e42-4e12-8cee-d19560671045
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dimension Vista® System PSA CAL
• Version Model Number: 10464359
• Catalog Number: KC602
• Company DUNS: 005088112
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: XX@XX.XX
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: CONTACT@SIEMENS-HEALTHINEERS.COM
• Phone: +1(800)441-9250
• Email: 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
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842768024214 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-24

Devices Manufactured by Siemens Healthcare Diagnostics Inc.

• 00630414306438 - ADVIA CHEM Ecre3: 2024-04-26 Creatinine enzymatic - ADVIA Chem. - RGT
• 00630414313450 - Atellica CH Billirubin Calibrator (BILI CAL): 2024-04-11 Atellica CH Bilirubin Calibrator (BILI CAL)
• 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