cobas SARS-CoV-2 Quality Control Kit

Basic Information

• Brand Name: cobas SARS-CoV-2 Quality Control Kit
• Primary DI: 00875197006759
• Version / Model: 09408835190
• Catalog Number: 09408835190
• Company Name: Roche Molecular Systems, Inc.
• Labeler DUNS: 071674100
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-24
• Public Version: 1
• Public Version Date: 2026-03-04
• Public Version Status: New
• Public Device Record Key: ccba2ce3-1386-4fb3-8b9d-a52b8b2aa117

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• 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
QWR	Simple point-of-care device to detect SAR-CoV-2 nucleic acid targets from clinical specimens in near-patient settings	Microbiology	866.3982	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64748	SARS-CoV-2 nucleic acid IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2), the causative agent for COVID-19, in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00875197006759	GS1

Premarket Submissions

Submission Number	Supplement Number
K223783	000