Elecsys free PSA 09744908190

GUDID 07613336217672

Roche Diagnostics GmbH

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

• Primary Device ID: 07613336217672
• NIH Device Record Key: 4d6527ce-7fbe-485e-a8fa-2dae72e29f77
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys free PSA
• Version Model Number: 09744908190
• Catalog Number: 09744908190
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336217672 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P000027

FDA Product Code

• LTJ: PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS

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: 2024-11-01
• Device Publish Date: 2024-10-24

On-Brand Devices [Elecsys free PSA]

• 04015630940011: 07027320190
• 07613336166628: 08828610190
• 07613336166673: 08828601160
• 07613336217672: 09744908190