AccessGUDID - DEVICE: Sunquest Mitogen Genetics (B236SMG6300)

GUDID

Device Identifier (DI) Information

Brand Name: Sunquest Mitogen Genetics
Version or Model: 6.3
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: CliniSys, Inc

Primary DI Number: B236SMG6300
Issuing Agency: HIBCC
Commercial Distribution End Date: October 09, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 052934841 *Terms of Use

Device Description: Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information.

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:	No
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?
61777	Human genomic analysis interpretive software	An interpretive software program intended to be used for the analysis and visualization of human genome data from in vitro diagnostic (IVD) 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. This software is not an IVD device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical Device Data System

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: 562453c2-2465-4b50-970a-ec5fa0fd68ef
Public Version Date: July 24, 2023
Public Version Number: 4
DI Record Publish Date: November 12, 2020