FDA.reportPublic FDA data

Clinisys SQ Lab

Primary DI
B236SQLAB202420
Brand
Clinisys SQ Lab
Company
CliniSys, Inc
Model
2024.2
Device description
Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory.Clinisys SQ Lab is intended for use only by professionals who have received extensivetraining in the use of the software. Clinisys SQ Lab is controlled via user defined securitylevels, which allow the laboratories to manage data security and integrity. The system is marketed as an automated solution for managing laboratory processes, including:• Patient registration• Order entry and order modification• Specimen collection, verification, suitability, and distribution• Quality assurance checking• Workload recording• Billing charge capture• Standards and controls recording• Test order result inquiry and reporting• Organism susceptibility and epidemiology records• Microbiology culture direct examination and observation recording• Outreach clients, specimens, and results• Client-specific reporting capabilities• Inbound client service request tracking• Historical data
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JQPCalculator/Data Processing Module, For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B236SQLAB202420PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Clinical laboratory information system application softwareAn 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.

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
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
B236CLS202330Clinisys Laboratory Solution2023.32024-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142373012SoftPathSCC SOFT COMPUTERJQP2026-05-29
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28
00810142373715SoftBiochemistrySCC SOFT COMPUTERJQP2026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTERJQP2026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTERJQP2026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTERJQP2026-03-12
00810142373753SoftHLASCC SOFT COMPUTERJQP2026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTERJQP2026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTERJQP2026-03-12
00810142373784SoftTrackSCC SOFT COMPUTERJQP2026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTERJQP2026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTERJQP2026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-21
00810142373630SoftHLASCC SOFT COMPUTERJQP2026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTERJQP2026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTERJQP2026-02-21
00810142373661SoftTrackSCC SOFT COMPUTERJQP2026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-04