Elecsys PreciControl Tumor Marker 11776452160

GUDID 04015630938780

Roche Diagnostics GmbH

Multiple tissue-associated protein/tumour marker IVD, control

• Primary Device ID: 04015630938780
• NIH Device Record Key: e218fb8a-c7ea-463e-ae5b-85e7f2529ef6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys PreciControl Tumor Marker
• Version Model Number: 11776452160
• Catalog Number: 11776452160
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630938780 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-09-16
• Device Publish Date: 2016-09-20

Devices Manufactured by Roche Diagnostics GmbH

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• 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