NGStrack DEMO Kit v2 Chimerism typing and monitoring by NGS (48)

Basic Information

• Brand Name: NGStrack DEMO Kit v2 Chimerism typing and monitoring by NGS (48)
• Primary DI: 00613745003832
• Version / Model: 8255520
• Company Name: GenBio
• Labeler DUNS: 940425333
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-26
• Public Version: 3
• Public Version Date: 2026-04-20
• Public Version Status: Update
• Public Device Record Key: 77e05e1f-e2de-4418-9a83-53813a8c26bf

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• 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
MZI	Test, Qualitative, For Hla, Non-Diagnostic	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
56403	HLA class I & II antigen nucleic acid tissue typing IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple HLA class I and II antigens in a clinical specimen, using a nucleic acid technique method (NAT).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613745003832	GS1