Specification Brand : OSOM BulletPoint1 : Detect influenza type A and B in just 10 minutes with minimal hands-on time, simplified workflow, and two additional tests for quality testing at no additional charge BulletPoint2 : Fast diagnosis—read test results in just 10 minutes BulletPoint3 : Trust your results—high sensitivity and specificity for more accurate diagnosis BulletPoint4 : Save time—pre-filled extraction buffer vial to reduce hands-on time BulletPoint5 : QC Inside—two extra tests included at no additional charge to run external quality control testing for more confidence in your results DiagnosticTestSampleType : np Directions : See package insert ExternallyAssignedProductIdentifier : 00742860100390 ExternallyAssignedProductIdentifier1 : 0627987040210 ExternallyAssignedProductIdentifier2 : 627987040210 ExternallyAssignedProductIdentifier3 : 00695684730406 FcShelfLife : 180 days FdaDeviceClassification : ii FdaIndicationOfUse : rx FdaInstructionsForUseType : professional FdaLabelType : rx_only FdaPremarketApprovalNumber510k : K010582 IncludedComponents : 40 test dipsticks, Rayon swabs, extraction tubes, A&B Extraction reagents IsExpirationDatedProduct : 1 IsLotControlledProduct : 1 ItemName : Sekisui Diagnostics Osom Ultra Plus Flu A&B Test Kit, 25 tests plus 2 additional tests for external QC ItemPackageDimensions_Height : 3 inches ItemPackageDimensions_Length : 8 inches ItemPackageDimensions_Width : 5 inches ItemPackageQuantity : 1 ItemTypeKeyword : professional-medical-clinical-diagnostic-test-kits Manufacturer : SEKISUI Diagnostics MedicalDiagnosticTestMethodology : antibody_rdt ModelNumber : 73040 NumberOfBoxes : 1 NumberOfItems : 1 PackageLevel : unit PartNumber : 1032 ProductDescription : Place a single tablet in the toilet bowl and observe it quickly dissolve and turn the water blue in a matter of seconds. Professional quality product and guaranteed to work. ProductExpirationType : Expiration On Package ProductSiteLaunchDate : 2019-07-23T18:44:33.617Z RegulatoryComplianceCertification : K192719 SafetyDataSheetUrl : https://sekisuidiagnostics.com/wp-content/uploads/2023/01/OSOM-Ultra-Plus-Flu-AB-Extraction-Buffer-Sekisui-1032-SDS_US-English.pdf Size : 40 Tests StreetDate : 2017-10-23T00:00:01Z SupplierDeclaredDgHzRegulation : not_applicable TemperatureRating : Ambient: 15 to 25 C (59 to 77 F) TestType1 : Array TestType2 : Array UnitCount : 100