Sofia 2

Basic Information

• Brand Name: Sofia 2
• Primary DI: 30014613339755
• Version / Model: 20405
• Catalog Number: 20405
• Company Name: QUIDEL CORPORATION
• Labeler DUNS: 079509836
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-28
• Public Version: 1
• Public Version Date: 2023-04-05
• Public Version Status: New
• Public Device Record Key: 92caa66c-ec84-4061-a1ce-f42b9b879a57

Device Description

Sofia 2 SARS Ag + FIA

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QVF	Simple point-of-care device to directly detect SARS-CoV-2 viral targets from clinical specimens in near-patient settings	Microbiology	866.3982	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64828	SARS-CoV-2 antigen IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antigens from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a fluorescent immunoassay method. This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613339755	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
DEN220039	000