cobas i 601 SBL 10271574001

GUDID 07613336231357

Roche Diagnostics GmbH

Liquid chromatography/mass spectrometry (LC/MS) analyser IVD

• Primary Device ID: 07613336231357
• NIH Device Record Key: 511c4b10-ab12-413b-adc5-1ea06dab4eb0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas i 601 SBL
• Version Model Number: 10271574001
• Catalog Number: 10271574001
• 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	07613336231357 [Primary]

FDA Product Code

• DOP: MASS SPECTROMETER, 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: 2025-08-18
• Device Publish Date: 2025-08-08

Devices Manufactured by Roche Diagnostics GmbH

• 07613336231357 - cobas i 601 SBL: 2025-08-18
• 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
• 07613336231364 - cobas i 601: 2025-08-08
• 07613336179444 - Elecsys Anti-SARS-CoV 2: 2025-07-30