Specification Brand : Sekisui Diagnostics BulletPoint1 : Sekisui Diagnostics Osom Ultra Plus Flu A&B Test Kit (25 Tests) - Strong Performance Takes Lateral Flow Testing To The Next Level. Providing superior rapid results at the point-of-care. BulletPoint2 : Fast, easy, cost effective so you can test in one visit. BulletPoint3 : Made in the USA. BulletPoint4 : Simple CLIA-waived procedure with pre-measured buffer for swab samples. Dipstick test format. Accurate, differentiated interpretation of results in 10 minutes. BulletPoint5 : Meets the reclassification requirements for rapid antigen tests. Includes: (25) Test Sticks, (25) Sterile Nasal Swabs, (25) Buffer Vials, (1) A+ Control Swab, (1) B+ Control Swab, IFU, QRG, (1) Workstation ExternallyAssignedProductIdentifier : 10817415024036 ExternallyAssignedProductIdentifier1 : 0850052493042 ExternallyAssignedProductIdentifier2 : 850052493042 FdaDeviceClassification : i FdaIndicationOfUse : rx FdaInstructionsForUseType : professional FdaLabelType : rx_only ItemName : Sekisui Diagnostics Osom Ultra Plus Flu A&B Test Kit, 25 Tests/Box (18 Boxes/Case) ItemPackageDimensions_Height : 10 inches ItemPackageDimensions_Length : 20 inches ItemPackageDimensions_Width : 10 inches ItemTypeKeyword : professional-medical-clinical-diagnostic-test-kits Manufacturer : Sekisui Diagnostics NumberOfItems : 18 NumberOfPieces : 5 PackageLevel : case PartNumber : 1032 ProductDescription : Sekisui Diagnostics Osom Ultra Plus Flu A&B Test Kit (25 Tests) - Strong Performance Takes Lateral Flow Testing To The Next Level - OSOM Ultra Plus Flu A&B Test, (1032) 25 Tests (plus 2 extra for external QC). Providing superior rapid results at the point-of-care. Fast, easy, cost effective so you can test in one visit. High Performance: Near or exceeding traditionally more sensitive reader devices without the need for an instrument. Results in 10 minutes. Made in the USA. Includes: (25) Test Sticks, (25) Sterile Nasal Swabs, (25) Extraction Buffer Vials, (2) Swabs, IFU, QRG, (1) Workstation ProductSiteLaunchDate : 2023-04-13T23:11:26.653Z Size : Case (18 boxes) SupplierDeclaredDgHzRegulation : not_applicable TestType : Array UnitCount : 1