NGSengine Standard Entry (1 year)

Basic Information

• Brand Name: NGSengine Standard Entry (1 year)
• Primary DI: 00613745003818
• Version / Model: 4109940
• 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: 82d4bf63-3688-4c8c-a175-fbe45b791d75

Device Characteristics

• Single Use: No
• 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
65871	Human genomic analysis interpretive software IVD	An in vitro diagnostic interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic results obtained through molecular genetic testing (e.g., whole genome, targeted genome, or exome analyses). It provides predictive and/or diagnostic information (e.g., gene-drug associations, congenital and/or acquired aneuploidy status, genotype-phenotype relationships) used by a professional in the assessment of patient adverse health condition risk, disease prevention, and/or health management, or for lifestyle guidance as pertains to a patient genomic profile.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613745003818	GS1

Customer Contacts

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