Elecsys total PSA 07027966190

GUDID 04015630939824

Roche Diagnostics GmbH

Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 04015630939824
• NIH Device Record Key: f06070aa-9fee-4d37-9e67-11f89f98dce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys total PSA
• Version Model Number: 07027966190
• Catalog Number: 07027966190
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630939824 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-06
• Device Publish Date: 2018-07-16

On-Brand Devices [Elecsys total PSA]

• 04015630939824: 07027966190
• 07613336166000: 08791716160
• 07613336165997: 08791686160
• 07613336165980: 08791732190