FDA.reportPublic FDA data

Clinical laboratory information system application software

Definition
An application software program, routines, and/or algorithms used as or in an information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. It is typically supplied for installation into a dedicated information system used in the clinical laboratory or existing mainframe or decentralized computers/networks.
GUDID devices
826
Last updated
2026-07-15 00:47:57

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810142373814SoftTotalQCSCC SOFT COMPUTER5.0.0.122026-07-03
05060508820024ULTRA Laboratory Information SystemCIRDAN IMAGING LIMITED4.7, 4.8, 4.92019-10-08
00810055811908SoftLabSCC SOFT COMPUTER4.5.5.602021-04-20
00810055811915SoftROESCC SOFT COMPUTER4.5.5.602021-04-20
00810055811922SoftMicSCC SOFT COMPUTER4.5.5.602021-04-20
00810055816491SoftTotalQCSCC SOFT COMPUTER4.1.17.162023-01-28
00810142370721SoftBiochemistrySCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370738SoftCytogeneticsSCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370745SoftPathDxSCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370752SoftFlowCytometrySCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370769SoftHLASCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370776SoftMolecularSCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370783SoftGenePortalSCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370790SoftMicSCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370806SoftLabSCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370813SoftGenomicsSCC SOFT COMPUTER4.1.17.2482024-07-11
00810142370820SoftTrackSCC SOFT COMPUTER4.1.17.2482024-07-11
00810142371780SoftLabSCC SOFT COMPUTER4.5.8.112025-10-04
00810142371797SoftMicSCC SOFT COMPUTER4.5.8.112025-10-04
00810142372558SoftPathSCC SOFT COMPUTER4.4.7.32025-09-30
00810142372718SoftLabSCC SOFT COMPUTER5.0.0.102025-10-04
00810142372725SoftMicSCC SOFT COMPUTER5.0.0.102025-10-04
00810142372848SoftLabSCC SOFT COMPUTER4.0.9.22025-10-09
00810142372855SoftMicSCC SOFT COMPUTER4.0.9.22025-10-09
00810142373029SoftMicSCC SOFT COMPUTER5.0.0.122025-10-07
00810142373036SoftLabSCC SOFT COMPUTER5.0.0.122025-10-07
00810142373357SoftGenePortalSCC SOFT COMPUTER4.2.0.132025-11-22
00810142373586SoftTotalQCSCC SOFT COMPUTER1.0.11.12026-03-28
00810142373975SoftBiochemistrySCC SOFT COMPUTER4.3.0.22026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTER4.3.0.22026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTER4.3.0.22026-04-16
00810142374019SoftHLASCC SOFT COMPUTER4.3.0.22026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTER4.3.0.22026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTER4.3.0.22026-04-16
00810142374064SoftBiobankSCC SOFT COMPUTER1.0.1.132026-05-05
00859474006533SoftWebPlusSCC SOFT COMPUTER1.1.1.42021-09-01
13700962601867REMISOL AdvanceBeckman Coulter, Inc.2.22025-10-17
13700962601874REMISOL AdvanceBeckman Coulter, Inc.2.32025-10-17
15099590802073REMISOL AdvanceBeckman Coulter, Inc.2.42025-10-17
B180IMB028170Instrument ManagerDATA INNOVATIONS LLC8172020-06-08
B180IMB029000Instrument ManagerDATA INNOVATIONS LLC9002023-07-13
B236CLS202520Clinisys Laboratory SolutionCliniSys, Inc2025.22025-11-10
G600OL12SP5OMNI-LabOmnitech Labs Inc.12 SP52024-04-05
00810142373715SoftBiochemistrySCC SOFT COMPUTER4.3.0.12026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTER4.3.0.12026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTER4.3.0.12026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTER4.3.0.12026-03-12
00810142373753SoftHLASCC SOFT COMPUTER4.3.0.12026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTER4.3.0.12026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTER4.3.0.12026-03-12
00810142373784SoftTrackSCC SOFT COMPUTER4.3.0.12026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTER5.0.0.112026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTER4.2.0.212026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTER4.2.0.212026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTER4.2.0.212026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTER4.2.0.212026-02-21
00810142373630SoftHLASCC SOFT COMPUTER4.2.0.212026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTER4.2.0.212026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTER4.2.0.212026-02-21
00810142373661SoftTrackSCC SOFT COMPUTER4.2.0.212026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTER4.3.0.02026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTER4.3.0.02026-02-04
00810142373524SoftPathDxSCC SOFT COMPUTER4.3.0.02026-02-04
00810142373531SoftFlowCytometrySCC SOFT COMPUTER4.3.0.02026-02-04
00810142373548SoftHLASCC SOFT COMPUTER4.3.0.02026-02-04
00810142373555SoftMolecularSCC SOFT COMPUTER4.3.0.02026-02-04
00810142373562SoftGenomicsSCC SOFT COMPUTER4.3.0.02026-02-04
00810142373579SoftTrackSCC SOFT COMPUTER4.3.0.02026-02-04
03770035155057Lab ComposerBYG INFORMATIQUE12026-01-30
03770035155064POC ControllerBYG INFORMATIQUE12026-01-30
B236SQLAB202420Clinisys SQ LabCliniSys, Inc2024.22026-01-23
00810142373449SoftTotalQCSCC SOFT COMPUTER1.0.12.02026-01-15
00810142373678SoftGenePortalSCC SOFT COMPUTER4.2.0.142026-01-16
00810142373685SoftBiobankSCC SOFT COMPUTER1.0.1.122026-01-15
B236CATL202510Clinisys AtlasCliniSys, Inc2025.12026-01-06
B180IMB029010Instrument ManagerDATA INNOVATIONS LLC9012025-12-08
00810142373364SoftBiochemistrySCC SOFT COMPUTER4.2.0.202025-12-06
00810142373371SoftCytogeneticsSCC SOFT COMPUTER4.2.0.202025-12-06
00810142373388SoftPathDxSCC SOFT COMPUTER4.2.0.202025-12-06
00810142373395SoftFlowCytometrySCC SOFT COMPUTER4.2.0.202025-12-06