HLA Fusion™ Software (IVD)

Basic Information

• Brand Name: HLA Fusion™ Software (IVD)
• Primary DI: 00814695022571
• Version / Model: N/A
• Catalog Number: FUSPGR
• Company Name: ONE LAMBDA, INC.
• Labeler DUNS: 118289289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: ce117224-d30f-4f88-90d7-caea7044b907

Device Description

HLA Fusion Software for clinical diagnostics features analysis modules for One Lambda’s IVD products such as FlowPRA®, LABScreen®, LABType®, LCT™, Micro SSP™ and more.

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MZI	Test,Qualitative,For Hla,Non-Diagnostic	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
56560	HLA class I & II antibody screening IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used in screening for one or multiple antibodies to HLA class I and II antigens in a clinical specimen, using solid phase antigens together with a multiplex method.	No	Active
56398	HLA class I & II antigen tissue typing IVD, kit, multiplex	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple HLA class I and II antigens in a clinical specimen, using a multiplex method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814695022571	GS1

Customer Contacts

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