HIV 1/2 TEST ORAQUICK (Orasure) oral fl.,1self-test,5X4-1001
STD
SSDTHIVO250T
Valid Article
Account code:
60200
HS Code:
382290
Last Updated on:
08/08/2024, 22:01:34
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
W0105090302 - Hiv 1 / 2 - rt & poc
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
OC subscriptions: included in supply or field order tools (e.g. UniField)
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SC subscriptions: included in supply or field tools
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OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)
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HIV 1/2 TEST ORAQUICK (Orasure) oral fluid Self-test
CAUTION
This test is worded and codified by unit to make the order easier, but it is always packaged in kit of 250.
Definition
The OraQuick HIV 1/2 Self-Test is a single-use qualitative immunoassay used for self-testing for Human Immunodeficiency Virus Type 1 and 2 in oral fluid specimens.
Specifications
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Components
Each kit contains
- 250 single pouches with:
- a single use test device
- a dissecant
- a developer solution vial
- 1 test stand
- 1 instruction for use
Instructions for use
The OraQuick HIV Self-Test kit instructions for use must be followed carefully to get an accurate result.
Please consult the “Updated laboratory procedures, 2022” available online via the Laboratory working Group sharepoint page: Laboratory Procedures and Resources.
https://msfintl.sharepoint.com/sites/msfintlcommunities/LabWG/SitePages/Laboratory-Manual-page.aspx
For offline access, contact your laboratory advisor.
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Precautions for Use
- Use with oral fluid only. The test is not for use with blood, serum, breast milk, plasma, semen, urine, vaginal fluid or sweat.
- Do not eat or drink 15 minutes before starting testing
- Do not use mouth cleaning products (such as mouth wash) 30 minutes before starting the test.
- Remove dental products such as dentures or any other products that cover your gums prior the oral fluid collection
- Do not use the test if you are on HIV treatment (ARVs) as false results may occur.
- The test may not detect HIV infections that have occurred within 3 months of a risk event. If the test is negative, re-test 3 months after the risk event.
Storage
Between 2-30°C
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