Specification Brand : MediChoice BulletPoint : Pap Smear Kit (2-pcs) BulletPoint1 : Used to qualitatively detect Strep A antigen from throat swab specimens BulletPoint2 : Sensitivity 97%, Specificity 95% BulletPoint3 : Easy-to-read results ready within 5 minutes BulletPoint4 : FDA Cleared and CLIA Waived BulletPoint5 : Immunostics IDSTREP-25 (25 Tests) Color : Lead ExternallyAssignedProductIdentifier : 9153749950868 ExternallyAssignedProductIdentifier1 : 859819005221 ExternallyAssignedProductIdentifier2 : 0859819005221 FdaDeviceClassification : iv FdaIndicationOfUse : otc_and_rx FdaInstructionsForUseType : consumer FdaLabelType : consumer ItemName : Detector Strep A Rapid Test Kit, Throat Swabs, CLIA Waived, IDSTREP-25 (Box of 25) ItemPackageDimensions_Height : 3.1 inches ItemPackageDimensions_Length : 8.2 inches ItemPackageDimensions_Width : 4.9 inches ItemPackageQuantity : 1 ItemTypeKeyword : professional-medical-clinical-diagnostic-test-kits Manufacturer : MediChoice Material : Paper ModelNumber : IDSTREP-25 NumberOfBoxes : 1 NumberOfItems : 25 NumberOfPieces : 25 PartNumber : IDSTREP-25 ProductDescription : Detector Strep A is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. The Rapid Strep Test (RST), or rapid antigen detection test (RADT), is an in-office test done by a clinician in order to determine whether or not a patient has streptococcal pharyngitis (colloquially called 'strep throat' in American English), which is a group A streptococcal infection of the pharynx and possibly other parts of the body. The Rapid Strep Test is one of the most common tests for streptococcal pharyngitis. Test Kit Includes : 25 Dipsticks, 1 Vial Reagent A, 1 Vial Reagent B, 1 Vial Positive Control, 1 Vial Negative Control, Workstation, Procedure Card, 25 Disposable extraction test tubes, 25 Swabs, and 1 Product Insert. MediChoice is Owens & Minor's brand of medical-surgical products and durable medical equipment that is expanding to meet the changing needs of healthcare. MediChoice, your choice for quality, value and unmatched service. Search MediChoice for additional product offerings. ProductExpirationType : Does Not Expire ProductSiteLaunchDate : 2016-09-27T22:28:32.533Z Size : 1 Count (Pack of 25) StreetDate : 2018-08-23T00:00:01Z Style : Rainbow SupplierDeclaredDgHzRegulation : not_applicable SupplierDeclaredHasProductIdentifierExemption : 1 TemperatureRating : Frozen: <2 C (<35 F) TestType : Array UnitCount : 25