The QuickVue iFOB test is an FDA-cleared and CLIA-waived
rapid immunochemical diagnostic tool
intended
to detect the presence
of blood in stool specimens. Blood in the stool is an indication
of a number
of gastrointestinal disorders, including colorectal cancer.
Description: 20 Test Kit, Includes:1 Pkg Insert,
1 Procedure Card, 20 Individually Wrapped Test
Cassettes, 20 Specimen Collection &
Return Kits Each Containing 1 Collection Tube w/2mL FOB Buffer,
1 Collection Paper w/adhesive, 1 Pouch, 1 Absorbent Sleeve, 1 Return Mail Box & 1 Patient Instructions
Features & Benefits
| Feature |
Benefit |
| Bold Burgundy Color End Points: |
Easy to read test results. |
| 5 to 10 Minutes to Result: |
Allows prompt diagnosis and treatment scheduling. |
| 1 Step Procedure: |
Fewer procedural steps. Decreases risk of operator error. |
| Pictorial Procedure Guide: |
Simplifies understanding of test procedure. |
| Immunochemical Assay: |
Specific to human hemoglobin, unlike Guaiac-based tests which also detect peroxidase activity and animal blood from food. |
| Room Temperature Storage: |
Requires no reagent warm-up. Use as needed without waiting. Does not take up refrigerator space. |
| 24 Month Dating*: |
Provides flexibility for low volume labs. |
| Built-in Internal Control: |
Indicates an adequate volume of specimen was used. |
| Patented Specimen Collection Tube: |
Convenient, odor-free collection tube functions as specimen applicator and allows for shortýterm storage of sample. Specimen remains hydrated maintaining the integrity of the sample. |
| No dietary restrictions: |
Improves patient compliance. |
| No medication restrictions: |
Improves patient compliance. |
| USPS Compliant Packaging: |
Provides for safe and efficient specimen transport. (Excluding product 20201) |
| Assigned CPT Code (G0328): |
Recognized by Medicare for reimbursement. See Reimbursement section below for more information. |
| External Kit Controls Available: |
Facilitates internal laboratory quality control. |
| Technical Support: |
Professional staff available for assistance. |
| * From date of manufacture |
-Product No: QDL-20194
-FDA 510K/ Clia Waived
-Reimbursement Info:
QuickVue iFOB
Immunochemical fecal occult blood test
Diagnostic Use: All payers
Screening Use: Non Medicare/Medicaid payers, 82274QW*, $23.22
QuickVue iFOB
Immunochemical fecal occult blood test
Screening Use: Medicare & Medicaid only, G0328QW*, $23.22