Name: HIV TEST, ORAQUICK ADV RAPID 1/2 (25TEST/BX)
• The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test detects antibodies to HIV-1 and HIV-2 in 20 minutes
• Approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens
• Complexity: Waived for Oral Fluid, Fingerstick Whole Blood and Venipuncture Whole Blood
• Complexity: Moderate for plasma samples
• The OraQuick ADVANCE® rapid test is comprised of a single-use test device and a single-use vial containing a pre-measured amount of a buffered developer solution
• Each component is sealed in separate compartments of a single pouch to form the test
• An oral fluid specimen is collected using the flat pad on the test device, followed by the insertion of the device into the vial of developer solution
• Store unused, unopened test kits at 2 - 27 degrees C (35 - 80 degrees F)
• WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov
- Application:
- Sexual Health Test Kit
- CLIA Classification:
- CLIA Waived for Whole Blood, Saliva / CLIA Moderate Complexity for Plasma
- CLIA Classified:
- CLIA Waived Sample Dependent
- Contents 1:
- (25) Divided Pouches with Test Device and 1 mL Vial Developer Solution, (5) Reusable Test Stands, (25) Specimen Collection Loops, (25) Information Pamphlets, Package Insert, Customer Letter
- Image Reference Number 2:
- 773625_usage.jpg
- Is_Active_Vendor:
- Y
- Is_DSCSA:
- N
- Is_Discontinued:
- N
- Is_Medical_Device:
- N
- Lot_Tracking_Flag:
- Y
