Elecsys Total -Tau CSF 08846634160

GUDID 07613336221761

Roche Diagnostics GmbH

Tau protein IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 07613336221761
• NIH Device Record Key: d17353e3-7555-4d45-982d-53cf48e08902
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Total -Tau CSF
• Version Model Number: 08846634160
• Catalog Number: 08846634160
• 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	07613336221761 [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: 2023-08-31
• Device Publish Date: 2023-08-23

Devices Manufactured by Roche Diagnostics GmbH

• 04015630037025 - cobas b 123 Fluid Pack 400: 2024-08-07
• 04015630037032 - cobas b 123 Fluid Pack 700: 2024-08-07
• 04015630037049 - cobas b 123 Fluid Pack 200: 2024-08-07
• 04015630037636 - cobas b 123 Fluid Pack COOX 200: 2024-08-07
• 04015630037643 - cobas b 123 Fluid Pack COOX 400: 2024-08-07
• 04015630037650 - cobas b 123 Fluid Pack COOX 700: 2024-08-07
• 07613336170304 - Elecsys PTH: 2024-08-07 E2G 300 count
• 07613336170311 - CalSet PTH: 2024-08-07