Rickettsia IFA IgM

Basic Information

• Brand Name: Rickettsia IFA IgM
• Primary DI: 20816101020250
• Version / Model: IF0100M
• Catalog Number: IF0100M
• 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: 23078e21-7275-4805-b367-38fac58fe0f7

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
GPN	Antiserum, Typhus Fever	Microbiology	866.3500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
51431	Rickettsia conorii immunoglobulin M (IgM) 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 M (IgM) antibodies to Rickettsia conorii in a clinical specimen, using a fluorescent immunoassay method. The assay is designed to detect infection with Rickettsia conorii, the rickettsial bacteria from the Spotted Fever Group.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20816101020250	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K864110	000

Storage Conditions

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