Rickettsia IFA IgM IF0100M

GUDID 20816101020250

DIASORIN MOLECULAR LLC

Rickettsia conorii immunoglobulin M (IgM) antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 20816101020250
• NIH Device Record Key: 23078e21-7275-4805-b367-38fac58fe0f7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rickettsia IFA IgM
• Version Model Number: IF0100M
• Catalog Number: IF0100M
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com
• Phone: 1-562-240-6500
• Email: TS.Molecular@DiaSorin.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101020250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864110

FDA Product Code

• GPN: Antiserum, Typhus Fever

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-23
• Device Publish Date: 2026-03-13

Devices Manufactured by DIASORIN MOLECULAR LLC

• 20816101020243 - Rickettsia IFA IgG: 2026-03-23
• 20816101020250 - Rickettsia IFA IgM: 2026-03-23
• 20816101020250 - Rickettsia IFA IgM: 2026-03-23
• 20816101020342 - Q Fever IFA IgG: 2026-03-23
• 20816101020359 - Q Fever IFA IgM: 2026-03-23
• 20816101020397 - Arbovirus IFA IgG: 2026-03-23
• 20816101020403 - Arbovirus IFA IgM: 2026-03-23
• 10816101025142 - LIAISON NES® Instrument: 2026-01-30
• 10816101025159 - LIAISON NES® Instrument (Refurbished): 2026-01-30