CalSet Total-Tau 07357010190

GUDID 07613336149874

Roche Diagnostics GmbH

Tau protein IVD, calibrator

• Primary Device ID: 07613336149874
• NIH Device Record Key: d193ae58-cea0-4dd5-9c69-be2c05b5421f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CalSet Total-Tau
• Version Model Number: 07357010190
• Catalog Number: 07357010190
• 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	07613336149874 [Primary]

FDA Product Code

• JIT: Calibrator, secondary

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: 2023-08-21
• Device Publish Date: 2023-08-11

Devices Manufactured by Roche Diagnostics GmbH

• 04015630939114 - Elecsys BRAHMS PCT: 2026-02-09
• 04015630940073 - Elecsys BRAHMS PCT: 2026-02-09
• 07613336224281 - PreciControl Rubella IgG: 2026-02-05
• 07613336206737 - VENTANA DP 600 slide scanner: 2025-12-23
• 07613336232125 - Ionify Steroids 1: 2025-12-19 Ionify Estradiol Ionify Androstenedione
• 07613336232132 - Ionify Steroids 2: 2025-12-19 Ionify DHEA Ionify DHEA-S Ionify 17-Hydroxyprogesterone Ionify Progesterone
• 07613336216958 - CalSet Phospho-Tau (181P) Plasma: 2025-11-26
• 07613336216965 - PreciControl Phospho-Tau (181P) Plasma: 2025-11-26