Elecsys Tg II 08906564190

GUDID 07613336169582

Roche Diagnostics GmbH

Thyroglobulin IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336169582
• NIH Device Record Key: ce6538aa-50ae-49e5-ac2d-67605ccc5edb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Tg II
• Version Model Number: 08906564190
• Catalog Number: 08906564190
• 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	07613336169582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221890

FDA Product Code

• MSW: System, test, thyroglobulin

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: 2023-11-08
• Device Publish Date: 2023-10-31

On-Brand Devices [Elecsys Tg II]

• 07613336203569: 08906556160
• 07613336169582: 08906564190