Elecsys CA 15-3 II 09755594190

GUDID 07613336218334

Roche Diagnostics GmbH

Cancer antigen 15-3 (CA15-3) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07613336218334
• NIH Device Record Key: ce22adf9-61b1-4321-8ed2-6b70d86e9960
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys CA 15-3 II
• Version Model Number: 09755594190
• Catalog Number: 09755594190
• 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	07613336218334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181492

FDA Product Code

• MOI: System, test, immunological, antigen, tumor

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: 2024-08-07
• Device Publish Date: 2024-07-30

Devices Manufactured by Roche Diagnostics GmbH

• 07613336227763 - Sodium electrode: 2025-03-13
• 07613336227770 - Potassium electrode: 2025-03-13
• 07613336227787 - Chloride electrode: 2025-03-13
• 07613336227794 - Reference electrode: 2025-03-13
• 07613336183045 - PreciControl Release HIV Gen II: 2025-02-27
• 07613336228487 - Elecsys Anti-HBc II: 2025-02-27
• 07613336228500 - Elecsys HIV Duo: 2025-02-27
• 07613336183212 - PreciControl HIV Gen II: 2025-02-27