Elecsys Free PSA CalCheck 03500373190

GUDID 04015630997053

Roche Diagnostics GmbH

Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control Free (unbound) prostate specific antigen (fPSA) IVD, control

• Primary Device ID: 04015630997053
• NIH Device Record Key: 55a93921-58e7-433a-bf9b-03aa0ce890b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Free PSA CalCheck
• Version Model Number: 03500373190
• Catalog Number: 03500373190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630997053 [Previous]
GS1	07613336154403 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000027
• Premarket Approval: P000027

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: 2014-12-18

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