Elecsys CA 125 II 09755586190

GUDID 07613336218327

Roche Diagnostics GmbH

Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336218327
• NIH Device Record Key: 9d94bc56-df65-4f78-9101-b720a6fb841d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys CA 125 II
• Version Model Number: 09755586190
• Catalog Number: 09755586190
• 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	07613336218327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143534

FDA Product Code

• LTK: TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)

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: 2024-08-21
• Device Publish Date: 2024-08-13

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• 07613336183137 - Elecsys HBsAg II Auto Confirm: 2024-11-15
• 07613336183168 - PreciControl HBsAg II: 2024-11-15
• 07613336183236 - PreciControl HBsAg II Auto Confirm: 2024-11-15
• 07613336234402 - navify® Lab Operations: 2024-11-05
• 07613336217665 - Elecsys Total PSA: 2024-11-01