Elecsys Phospho-Tau (181P) CSF 08846715190

GUDID 07613336167663

Roche Diagnostics GmbH

Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) Tau protein IVD, kit, enzyme immunoassay (EIA) 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