Sofia

Basic Information

• Brand Name: Sofia
• Primary DI: 30014613338772
• Version / Model: 20352
• Catalog Number: 20352
• Company Name: QUIDEL CARDIOVASCULAR INC.
• Labeler DUNS: 080890141
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-18
• Public Version: 1
• Public Version Date: 2025-11-26
• Public Version Status: New
• Public Device Record Key: 0fb2d791-c97a-4f93-93c3-44403a8c0fa3

Device Description

Sofia 2 Campylobacter FIA

Device Characteristics

• Single Use: No
• 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: No
• 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
LQP	CAMPYLOBACTER SPP.	Microbiology	866.3110	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50691	Multiple Campylobacter species antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to one or multiple species of Campylobacter bacteria, which may include C. coli, C. fetus and C. jejuni in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50014613338776	GS1	Case	12	In Commercial Distribution
Primary	30014613338772	GS1

Premarket Submissions

Submission Number	Supplement Number
K211342	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze, Store out of direct sunlight