{"publicDeviceRecordKey":"e8d91b0c-5b58-49d2-ad64-aaa5771148a5","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-02-02T00:00:00.000Z","devicePublishDate":"2026-01-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B236SQLAB202420","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Clinisys SQ Lab","versionModelNumber":"2024.2","catalogNumber":null,"dunsNumber":"052934841","companyName":"CliniSys, Inc","deviceCount":1,"deviceDescription":"Clinisys SQ Lab is intended for use by professionals working in a clinical laboratory.\nClinisys SQ Lab is intended for use only by professionals who have received extensive\ntraining in the use of the software. Clinisys SQ Lab is controlled via user defined security\nlevels, which allow the laboratories to manage data security and integrity. \nThe system is marketed as an automated solution for managing laboratory processes, including:\n• Patient registration\n• Order entry and order modification\n• Specimen collection, verification, suitability, and distribution\n• Quality assurance checking\n• Workload recording\n• Billing charge capture\n• Standards and controls recording\n• Test order result inquiry and reporting\n• Organism susceptibility and epidemiology records\n• Microbiology culture direct examination and observation recording\n• Outreach clients, specimens, and results\n• Client-specific reporting capabilities\n• Inbound client service request tracking\n• Historical data\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44082","gmdnPTName":"Clinical laboratory information system application software","gmdnPTDefinition":"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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JQP","productCodeName":"Calculator/Data Processing Module, For Clinical Use"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}