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Specification
Brand : Clarity Diagnostics
BulletPoint1 : Clarity Diagnostics ImmunoChemical Fecal Occult Blood Test Kit, CLIA Waived (DTG-FOB01) 30 Tests per Box. Clarity IFOBT Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT)
BulletPoint2 : Each Box Includes: (30) IFOB Test Cassettes, (35) Sample Collection Buffer Tubes, Positive Control, Negative Control, Package Insert
BulletPoint3 : No Food, Drug, or Vitamin Restrictions Required. Fasting Not Required, Only 1 Stool Sample Needed. 50ng/mL of Blood Sensitivity, 100% Specificity.
BulletPoint4 : 10 Times more Accurate than Traditional Guaiac Colorectal Cancer Screening Method. CLIA Waived
BulletPoint5 : Greater reliability vs. traditional guaiac tests (lower sensitivity 0.5 ugHb/ml). Test Type: Colorectal Cancer Screening. Time to Results: 5 Minute Results
FdaDeviceClassification : ii
FdaIndicationOfUse : rx
FdaInstructionsForUseType : professional
FdaLabelType : rx_only
Hazmat : 9
IncludedComponents : IFOB Test Cassettes, Sample Collection Tubes, Controls, Package Insert
ItemName : Clarity Diagnostics ImmunoChemical Fecal Occult Blood Test Kit, CLIA Waived (DTG-FOB01) 30 Tests per Box
ItemPackageDimensions_Height : 10 inches
ItemPackageDimensions_Length : 10 inches
ItemPackageDimensions_Width : 10 inches
ItemPackageQuantity : 1
ItemTypeKeyword : professional-medical-clinical-diagnostic-test-kits
Manufacturer : Clarity Diagnostics, LLC
ModelNumber : DTG-FOB01
NumberOfBoxes : 1
NumberOfItems : 30
PartNumber : DTG-FOB01
ProductExpirationType : Does Not Expire
ProductSiteLaunchDate : 2018-05-08T08:00:01.000Z
StreetDate : 2018-05-08T00:00:01Z
SupplierDeclaredDgHzRegulation : not_applicable
UnitCount : 30
UnspscCode : 41131900