AccessGUDID - DEVICE: NGSengine Analysis Software for Non-Classical + Non-HLA Genes (00613745003757)

GUDID

Device Identifier (DI) Information

Brand Name: NGSengine Analysis Software for Non-Classical + Non-HLA Genes
Version or Model: 4103440
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GenBio

Primary DI Number: 00613745003757
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 940425333 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZI	Test, Qualitative, For Hla, Non-Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 18496ea3-738e-4f3b-beaa-231c2b964d80
Public Version Date: April 20, 2026
Public Version Number: 3
DI Record Publish Date: December 26, 2025