Elecsys beta-Amyloid (1-42) CSF II 08821941190

GUDID 07613336166321

Roche Diagnostics GmbH

Amyloid B component IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336166321
• NIH Device Record Key: f97d8946-9c68-4f30-b2fe-072d687816b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys beta-Amyloid (1-42) CSF II
• Version Model Number: 08821941190
• Catalog Number: 08821941190
• 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	07613336166321 [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: 2023-08-08
• Device Publish Date: 2022-12-17

On-Brand Devices [Elecsys beta-Amyloid (1-42) CSF II]

• 07613336208359: 08821909160
• 07613336166321: 08821941190