PreciControl Phospho-Tau (181P) Plasma 09697926190

GUDID 07613336216965

Roche Diagnostics GmbH

Tau protein IVD, control

• Primary Device ID: 07613336216965
• NIH Device Record Key: a104ae29-895f-4a93-8413-7f338a786004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreciControl Phospho-Tau (181P) Plasma
• Version Model Number: 09697926190
• Catalog Number: 09697926190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	07613336216965 [Primary]

FDA Product Code

• JJY: Multi-analyte controls, all kinds (assayed)

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: 2025-11-26
• Device Publish Date: 2025-11-18

Devices Manufactured by Roche Diagnostics GmbH

• 07613336216958 - CalSet Phospho-Tau (181P) Plasma: 2025-11-26
• 07613336216965 - PreciControl Phospho-Tau (181P) Plasma: 2025-11-26
• 07613336216965 - PreciControl Phospho-Tau (181P) Plasma: 2025-11-26
• 07613336231357 - cobas i 601 SBL: 2025-08-18
• 07613336231388 - cobas pro i 601 BL: 2025-08-18
• 07613336222713 - navify: 2025-08-08
• 07613336228630 - HPLC Cartridge (iHPLC): 2025-08-08
• 07613336228647 - Rapid Cartridge B (iRapidB): 2025-08-08
• 07613336228654 - Rapid Cartridge C (iRapidC): 2025-08-08