Oraquick HIV self-test, Kit/250

General Description:
The OraQuick HIV Self-Test is an in-vitro diagnostic medical device (IVD) that is used for self-testing of antibodies for HIV-1 and HIV-2 in oral fluid. This test is intended as an aid to detect antibodies to HIV-1 and HIV-2 from infected individuals.

Technical specifications:
Sample type: Oral fluid
Time to result: 20 - 40 mins

Manufacture product reference code:
OraSure Technologies Inc. (5X4-1001.###)


QMS/Regulatory information:
·ROW (Rest-of-World)
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
250 pouched kits: Each pouched kit contains:
·1 divided pouch with - a single use test device; and - a desiccant; and - a developer solution vial
·1 test stand
·1 IFU
·1 disposal bag

Items required, but not provided:
Clock, watch, or timing device

Shelf Life:
30 months from the date of manufacturing; do not use beyond its expiry date.
Weight and Volume:
Estimated weight: 10.00kg
Estimated volume: 0.12m³

Storage & transportation condition:
Between 2 to 30 °C. Protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of Oraquick HIV self-test for 250 tests
Secondary packaging: One kit Oraquick HIV self-test, 250 tests

General recommendations:
https://extranet.who. int/prequal/sites/default/files/whopr_files/PQDx_0159-055-01_OraQuick_HI V-SelfTest_v8.0.pdf

Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).