Dimension® clinical chemistry system FPSA Flex® reagent cartridge RF452

GUDID 00842768013881

Heterogeneous Immunoassay Module Free Prostate Specific Antigen Flex® reagent cartridge 120 Test

Siemens Healthcare Diagnostics Inc.

Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA) Free (unbound) prostate specific antigen (fPSA) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00842768013881
• NIH Device Record Key: 0cc6a483-3571-4674-8f20-d40d0345ddfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dimension® clinical chemistry system FPSA Flex® reagent cartridge
• Version Model Number: 10444888
• Catalog Number: RF452
• Company DUNS: 005088112
• Company Name: Siemens Healthcare Diagnostics Inc.
• Device Count: 4
• 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
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00630414601755 [Unit of Use]
GS1	00842768013881 [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: 6
• Public Version Date: 2020-02-06
• Device Publish Date: 2014-09-24

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