uTYPE™ CDx HLA Sequence Analysis Software

Basic Information

• Brand Name: uTYPE™ CDx HLA Sequence Analysis Software
• Primary DI: 00812117016849
• Version / Model: UTPCDX-PGR
• Catalog Number: UTPCDX-PGR
• Company Name: ONE LAMBDA, INC.
• Labeler DUNS: 118289289
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-30
• Public Version: 1
• Public Version Date: 2023-02-07
• Public Version Status: New
• Public Device Record Key: 2bf9bbd7-ed65-4fe8-85b8-e70ad02a77e0

Device Description

The uTYPE™ CDx HLA Sequence Analysis Software is intended to analyze sequencing data generated from the SeCore™ CDx HLA Sequencing system

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
QUK	Human Leukocyte Antigen (Hla) Typing Companion Diagnostic Test	Immunology	866.5960	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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	00812117016849	GS1

Customer Contacts

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