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Specification
Brand : QuickVue
BulletPoint : ARETE Pap Smear Kit (4-pcs)
BulletPoint1 : 92 percent sensitive; 99 percent specific
BulletPoint2 : Result in 5 minutes or less
BulletPoint3 : Two-color result for easy-to-interpret results
BulletPoint4 : CLIA Waived
BulletPoint5 : Room temperature storage
BulletPoint6 : Easy to interpret results with built-in procedural controls
BulletPoint7 : Interpretation of test results are: positive (one line), negative (two lines), invalid (no lines or no control line)
BulletPoint8 : Individually packaged strips for easy distribution
BulletPoint9 : Warning: This test does not evaluate drug safety or purity.
Color : Red
ContainsLiquidContents : 1
DsaResponsiblePartyAddress : tomjcrisman@gmail.com
ExternallyAssignedProductIdentifier : 30014613003434
ExternallyAssignedProductIdentifier1 : 724832097556
ExternallyAssignedProductIdentifier2 : 0724832097556
ExternallyAssignedProductIdentifier3 : 00724832097556
FabricType : 100% Rayon
FcShelfLife : 180 days
FdaDeviceClassification : i
FdaIndicationOfUse : rx
FdaInstructionsForUseType : professional
FdaLabelType : rx_only
FdaPremarketApprovalNumber510k : K934484
IncludedComponents : Test strips with microscoops, Results Interpretation Card, Product insert
Ingredients : instructions for registration and collection, urine collection funnel, urine collection tube with preservative, label for collection tube, reminder card, specimen container with absorbant pad, prepaid return shipping envelope
IsExpirationDatedProduct : 1
IsLiquidDoubleSealed : 1
IsLotControlledProduct : 1
ItemName : QuickVue Inline Strep A Test (Pack of 25)
ItemPackageDimensions_Height : 25.4 centimeters
ItemPackageDimensions_Length : 13.97 centimeters
ItemPackageDimensions_Width : 15.24 centimeters
ItemPackageQuantity : 1
ItemTypeKeyword : professional-medical-clinical-diagnostic-test-kits
LiquidContentsDescription : Preservative
LiquidVolume : 3.4 milliliters
Manufacturer : Quidel
Material : Plastic
ModelNumber : 00343
NumberOfBoxes : 1
NumberOfItems : 25
NumberOfPieces : 1
PartNumber : 00343
ProductDescription : Single test kit with for quick, uncomplex, clean and precise microscopic counting of Eosinophiles and Avian Leukocyte. Dilution 1:32. Including End-to-End-volume capillaries and chamber filling capillaries. For use with 20µL capillary or EDTA blood.
ProductExpirationType : Expiration On Package
ProductSiteLaunchDate : 2018-01-24T08:00:01.000Z
Size : 1 Count (Pack of 1)
SpecificUsesForProduct : Thyroid Test
StreetDate : 2018-01-24T00:00:01Z
SupplierDeclaredDgHzRegulation : not_applicable
SupplierDeclaredHasProductIdentifierExemption : 1
TemperatureRating : Ambient: 15 to 25 C (59 to 77 F)
TestType : Array
UnitCount : 25
UnspscCode : 46150000