total PSA CalSet II 08838534160

GUDID 07613336167496

Roche Diagnostics GmbH

Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator Total prostate specific antigen (tPSA) IVD, calibrator

• Primary Device ID: 07613336167496
• NIH Device Record Key: 91730135-ad11-4590-9c31-8822a3a2043d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: total PSA CalSet II
• Version Model Number: 08838534160
• Catalog Number: 08838534160
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336167496 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990056

FDA Product Code

• MTF: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-01
• Device Publish Date: 2020-08-24

On-Brand Devices [total PSA CalSet II]

• 07613336154380: Total PSA G2 CS Elecsys V2.1
• 07613336167496: 08838534160