SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0159-055-01
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Standard
Product name
Oraquick HIV Self Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HIV self-test
Regulatory Version Submitted To PQ
Rest-of-World
Applicant organization
OraSure Technologies, Inc.
220 East First Street
Bethlehem,
18015
United States of America
Pathogen
HIV
Specimen Type
Oral fluid
Product Code
Identification name
5X4-1000.###
Test kit package size
50
Test Package Size
Country-specific variations are documented through a suffix “###” to the product code on the outer packaging (i
Identification name
5X4-1001.###
Test kit package size
250
Test Package Size
Country-specific variations are documented through a suffix “###” to the product code on the outer packaging (i
Identification name
5X4-2001.###
Test kit package size
200
Test Package Size
• 1 instructions for use
• 1 disposal bag
• 1 disposal bag
Identification name
5X4-7000.200
Test Package Size
• 1 instruction for use
• 1 disposal bag
• 1 disposal bag
Identification name
5x4-0004.###
Test kit package size
1
Test Package Size
The single pouch product code REF 5X4-0004