Lambda Antigen Tray™ Class I & II

Basic Information

• Brand Name: Lambda Antigen Tray™ Class I & II
• Primary DI: 00812117018669
• Version / Model: N/A
• Catalog Number: LATP1240
• Company Name: ONE LAMBDA, INC.
• Labeler DUNS: 118289289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-11
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7726a323-ec8f-4df4-87fb-db6909890a0a

Device Description

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.

Device Characteristics

• Single Use: Yes
• 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: Yes
• 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
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812117018669	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 5 Degrees Celsius