LIAISON® XL Zika Capture IgM II

Basic Information

• Brand Name: LIAISON® XL Zika Capture IgM II
• Primary DI: 08056771602624
• Version / Model: 317150
• Company Name: Diasorin Inc.
• Labeler DUNS: 033429783
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-04
• Public Version: 1
• Public Version Date: 2019-12-12
• Public Version Status: New
• Public Device Record Key: 27502a43-c99b-413f-8442-fac932691b22

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
QFO	Zika Virus Serological Reagents	Microbiology	866.3935	2

GMDN Terms

Code	Name	Definition	Implantable	Status
49107	Zika virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent 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 Zika virus in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056771602624	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192046	000