Elecsys Total-Tau CSF 08846685190

GUDID 07613336167649

Roche Diagnostics GmbH

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• Primary Device ID: 07613336167649
• NIH Device Record Key: dac28473-0f78-406d-8d83-a01b6df52484
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Total-Tau CSF
• Version Model Number: 08846685190
• Catalog Number: 08846685190
• 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	07613336167649 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231348

FDA Product Code

• QSE: Alzheimer’s disease pathology assessment test

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: 2023-08-21
• Device Publish Date: 2023-08-11

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