{"publicDeviceRecordKey":"568fa708-11c1-435f-86f7-232d5e025a7a","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2022-03-22T00:00:00.000Z","devicePublishDate":"2016-09-17T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00849832007883","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Leica Biosystems Ariol Camera Large, Jai CVM2","versionModelNumber":"23ACM2","catalogNumber":null,"dunsNumber":"082930884","companyName":"Leica Biosystems Richmond, Inc.","deviceCount":1,"deviceDescription":"Leica Biosystems Ariol Camera Large, Jai CVM2","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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(866)4783999","phoneExtension":null,"email":"tech.support@Leicabiosystems.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35576","gmdnPTName":"Surgical microscope still camera","gmdnPTDefinition":"An electro-optical device intended to be used to capture and generate an enlarged image of a microscopic field for examination of a clinical specimen during a surgical procedure. It is designed to attach to a surgical microscope and utilizes the lens system for magnification of the microscope’s field; the images generated are used for subsequent clinical decision-making. This device may be a digital or photographic camera; some types may in addition be used with laboratory microscopes.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NQN","productCodeName":"MICROSCOPE,AUTOMATED,IMAGE ANALYSIS,IMMUNOHISTOCHEMISTRY,OPERATOR INTERVENTION,NUCLEAR INTENSITY \u0026 PERCENT POSITIVITY"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":null}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":null}]},"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":[]}}