FDA.reportPublic FDA data

Sunquest Mitogen Genetics

Primary DI
B236SMG6300
Brand
Sunquest Mitogen Genetics
Company
CliniSys, Inc
Model
6.3
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.
Published
2020-11-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
OUGMedical Device Data System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OUGMedical Device Data SystemGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B236SMG6300PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Human genomic analysis interpretive softwareAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
052934841
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B236CPP8030Clinisys CoPathPlus8.0.32026-02-18
B236SQBB202420Clinisys SQ Blood Bank2024.22026-01-23
B236SQLAB202420Clinisys SQ Lab2024.22026-01-23
B236CATL202510Clinisys Atlas2025.12026-01-06
B236CLS202520Clinisys Laboratory Solution2025.22025-11-10
B236CLS202510Clinisys Laboratory Solution2025.12025-08-13
B236CATL202350Clinisys Atlas2023.52025-07-11
B236BB10110Sunquest Blood Bank10.1.12022-03-22
B236LAB10110Sunquest Laboratory10.1.12022-03-22
B236BB10010Sunquest Blood Bank10.0.12021-03-05
B236LAB10010Sunquest Laboratory10.0.12021-03-05
B236BB8010Sunquest Blood Bank8.0.12021-02-19
B236BB8130Sunquest Blood Bank8.1.32021-02-19
B236BB8230Sunquest Blood Bank8.2.32021-02-19
B236LAB8010Sunquest Laboratory8.0.12021-02-19
B236LAB8130Sunquest Laboratory8.1.32021-02-19
B236LAB8230Sunquest Laboratory8.2.32021-02-19
B236SQBB202410Clinisys SQ Blood Bank2024.12024-12-06
B236SQLAB202410Clinisys SQ Lab2024.12024-12-06
B236CATL202340Clinisys Atlas2023.42024-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675544227Connectivity Converter CC300Drägerwerk AG & Co. KGaAOUG2026-07-17
04260658860258myoncareONCARE GmbHOUG2026-07-17
00840241600443Kestra Provided Device Patient ApplicationKestra Medical Technologies, Inc.OUG2026-07-16
00884400004871GoClinicMonitored Therapeutics, Inc.OUG2026-07-16
00884400085481GoMobileMonitored Therapeutics, Inc.OUG2026-07-16
04035479194192PatientApp 2.10.0BIOTRONIK SE & Co. KGOUG2026-07-16
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-07-13
04048675558552Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558569Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675558576Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
04048675663997Vista GatewayShanghai Draeger Medical Instrument Co.,Ltd.OUG2026-07-13
00199150006038N/AMEDTRONIC, INC.OUG2026-05-23
04931921049464NANIHON KOHDEN CORPORATIONOUG2026-05-20
04931921111697NANIHON KOHDEN CORPORATIONOUG2026-05-20
00199150021277NAMEDTRONIC, INC.OUG2026-05-02
00199150042784NAMEDTRONIC, INC.OUG2026-04-30
00199874112060CliniSphereMonitored Therapeutics, Inc.OUG2026-04-28
00850022853036ProSomnus RPMO2 OSA DevicePROSOMNUS SLEEP TECHNOLOGIESOUG2026-04-24
00884838129238Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00884838129245Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-04-17
00199150002191N/AMEDTRONIC, INC.OUG2026-04-02
05404028001158Mimics FlowMaterialise NVOUG2026-03-23
05404028001172SurgiCase OnlineMaterialise NVOUG2026-03-23
05404028001189ProPlan CMF Materialise NVOUG2026-03-23
00763000994914NAMEDTRONIC, INC.OUG2026-03-22
00382904450106BD Veritor™ InfoWiFi ModuleBECTON, DICKINSON AND COMPANYOUG2026-03-13
00884838129214Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
00884838129221Care AssistPhilips Medizin Systeme Böblingen GmbHOUG2026-03-09
04035479189211PatientApp 2.9BIOTRONIK SE & Co. KGOUG2026-03-04