Specification Brand : Sekisui Diagnostics BulletPoint1 : Results in 5 minutes BulletPoint2 : 96.0 percent sensitivity, 97.8 percent specificity BulletPoint3 : Easy-to-read two color results BulletPoint4 : Copt code: 87880Qw BulletPoint5 : For laboratory and professional in vitro diagnostic use only ExternallyAssignedProductIdentifier1 : 742860001413 ExternallyAssignedProductIdentifier2 : 0742860001413 ExternallyAssignedProductIdentifier3 : 00742860001413 FdaDeviceClassification : i FdaIndicationOfUse : rx FdaInstructionsForUseType : professional FdaLabelType : rx_only FdaPremarketApprovalNumber510k : K961423 Hazmat : 9 IsExpirationDatedProduct : 1 IsLotControlledProduct : 1 ItemName : Sekisui Diagnostics OSOM Strep A Test, 50 Tests ItemPackageDimensions_Height : 3.75 inches ItemPackageDimensions_Length : 8.25 inches ItemPackageDimensions_Width : 4.75 inches ItemPackageQuantity : 1 ItemTypeKeyword : professional-medical-clinical-diagnostic-test-kits Manufacturer : Sekisui Diagnostics ModelNumber : 141 NumberOfBoxes : 1 NumberOfItems : 50 NumberOfPieces : 1 PartNumber : 141 ProductDescription : Cito Test HCV is a rapid test for detecting antibodies to the hepatitis C pathogen using samples such as blood, serum or plasma. The accuracy and specificity of the test is very high and amounts to 99, 99%. Result in 10 min. If a positive viral hepatitis C test result is confirmed repeatedly, it is important to understand the need to start treatment as soon as possible. Completeness: Test cassette, pipette, whole blood buffer, Instruction in Ukrainian. ProductExpirationType : Expiration Date Required ProductSiteLaunchDate : 2018-07-16T08:00:01.000Z SpecificUsesForProduct : Antibodies Test StreetDate : 2018-05-22T00:00:01Z SupplierDeclaredDgHzRegulation : not_applicable TemperatureRating : Cool: 9 to 14 C (48 to 58 F) UnitCount : 50