{"publicDeviceRecordKey":"a73e2a2b-ee70-44a1-b751-e59e7e8059af","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2022-03-22T00:00:00.000Z","devicePublishDate":"2017-01-12T00:00:00.000Z","deviceCommDistributionEndDate":"2018-01-25T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"07290016630008","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"GenASIs™ System","versionModelNumber":"GenASIs","catalogNumber":null,"dunsNumber":"600741763","companyName":"APPLIED SPECTRAL IMAGING LTD.","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K012103","supplementNumber":"000"},{"submissionNumber":"K050236","supplementNumber":"000"},{"submissionNumber":"K071398","supplementNumber":"000"},{"submissionNumber":"K101291","supplementNumber":"000"},{"submissionNumber":"K110345","supplementNumber":"000"},{"submissionNumber":"K122554","supplementNumber":"000"},{"submissionNumber":"K140957","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"42838","gmdnPTName":"Laboratory analyser operation system software IVD","gmdnPTDefinition":"Mainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a \"version number\" are commonly used to identify different operating system versions.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NTH","productCodeName":"System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays"},{"productCode":"LNJ","productCodeName":"Analyzer, Chromosome, Automated"},{"productCode":"NQN","productCodeName":"Microscope,Automated,Image Analysis,Immunohistochemistry,Operator Intervention,Nuclear Intensity \u0026 Percent Positivity"},{"productCode":"NOT","productCodeName":"Microscope, Automated, Image Analysis, Operator Intervention"},{"productCode":"JOY","productCodeName":"Device, Automated Cell-Locating"}]},"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}