Elecsys Phospho-Tau (181P) CSF 08846715190

GUDID 07613336167663

Roche Diagnostics GmbH

Tau protein IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07613336167663
• NIH Device Record Key: f48155f8-d996-47aa-b9bd-0875bc47784c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Phospho-Tau (181P) CSF
• Version Model Number: 08846715190
• Catalog Number: 08846715190
• 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	07613336167663 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221842

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-13
• Device Publish Date: 2022-12-17

On-Brand Devices [Elecsys Phospho-Tau (181P) CSF]

• 07613336208366: 08846693160
• 07613336167663: 08846715190