cobas pro SBL c 503 09205691001

GUDID 07613336179529

Roche Diagnostics GmbH

Ion-selective analyser IVD, automated

• Primary Device ID: 07613336179529
• NIH Device Record Key: 34f748ef-a744-44b3-b306-86d0171149c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas pro SBL c 503
• Version Model Number: 09205691001
• Catalog Number: 09205691001
• 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	07613336179529 [Primary]

FDA Product Code

• JJE: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

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: 2021-09-13
• Device Publish Date: 2021-09-03

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• 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
• 07613336231357 - cobas i 601 SBL: 2025-08-18
• 07613336231388 - cobas pro i 601 BL: 2025-08-18