Elecsys Total PSA Immunoassay 04641655160

GUDID 04015630921515

Roche Diagnostics GmbH

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

• Primary Device ID: 04015630921515
• NIH Device Record Key: d17b8e15-1c12-4751-9fd0-ea6208b02436
• Commercial Distribution Discontinuation: 2018-09-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Elecsys Total PSA Immunoassay
• Version Model Number: 04641655160
• Catalog Number: 04641655160
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630921515 [Previous]
GS1	07613336154366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990056
• 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: 5
• Public Version Date: 2020-02-06
• Device Publish Date: 2014-09-10

On-Brand Devices [Elecsys Total PSA Immunoassay]

• 04015630920877: 04491734160
• 04015630921515: 04641655160