cobas i 601 SBL

Basic Information

• Brand Name: cobas i 601 SBL
• Primary DI: 07613336231357
• Version / Model: 10271574001
• Catalog Number: 10271574001
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-08
• Public Version: 1
• Public Version Date: 2025-08-18
• Public Version Status: New
• Public Device Record Key: 511c4b10-ab12-413b-adc5-1ea06dab4eb0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DOP	MASS SPECTROMETER, CLINICAL USE	Clinical Chemistry	862.2860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63101	Liquid chromatography/mass spectrometry (LC/MS) analyser IVD	An electrically-powered automated or semi-automated laboratory instrument designed for the qualitative and/or quantitative in vitro determination of the chemical composition of a clinical specimen. The sample is introduced in a pressurized liquid and its compounds are separated based on their chemical/physical properties while interacting with a column filling; as the substances exit the column they are ionized and the resulting ions are separated according to mass using an electromagnetic field. The device is used for identification and quantification of complex substances (e.g., drugs, hormones).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613336231357	GS1