{"publicDeviceRecordKey":"35022ff1-c732-4dd1-8034-5c51da4d5291","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-11-28T00:00:00.000Z","devicePublishDate":"2021-05-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B224SB201","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TRI-SLIDE STOOL BLOOD TEST","versionModelNumber":"SB-20","catalogNumber":"SB-20","dunsNumber":"068288943","companyName":"CENOGENICS CORPORATION","deviceCount":1,"deviceDescription":"Cenogenics Corporation's TRI-SLIDE STOOL BLOOD TEST is a six test guaiac slide procedure to effectively screen for intermittent gastrointestinal bleeding.\nThe Kit Contains:\n    100 three-section slides with controls. Each section contains two test sites (6 tests/slide) and a positive and negative control set.\n    300 applicators\n    6 X 10ml developing solution\n    Product Instructions","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"(732) 536-6457","phoneExtension":null,"email":"info@cenogenics.net"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K761232","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"54531","gmdnPTName":"Faecal occult blood IVD, kit, rapid colorimetric, clinical","gmdnPTDefinition":"A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of stool (faeces) for occult blood (haemoglobin) within a short period relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KHE","productCodeName":"Reagent, Occult Blood"}]},"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}