Q Fever IFA IgG

Basic Information

• Brand Name: Q Fever IFA IgG
• Primary DI: 20816101020342
• Version / Model: IF0200G
• Catalog Number: IF0200G
• Company Name: DIASORIN MOLECULAR LLC
• Labeler DUNS: 080271715
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-13
• Public Version: 1
• Public Version Date: 2026-03-23
• Public Version Status: New
• Public Device Record Key: 03b3dca7-917b-49bc-94d6-58d56d484b43

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
GPJ	Antiserum, Fluorescent, Q Fever	Microbiology	866.3500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51351	Coxiella burnetii immunoglobulin G (IgG) 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 immunoglobulin G (IgG) antibodies to Coxiella burnetii in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Coxiella burnetii, the rickettsial bacteria associated with Q fever.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20816101020342	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K913906	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius