SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0244-055-01
Status
Prequalified
Date of prequalification
Basis of listing
Prequalification - Abridged
Product name
OraQuick Hepatitis C Self-Test
Assay Type
Immunochromatographic (lateral flow)
IVD Public Report Category
HCV 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
HCV
Specimen Type
Oral fluid
Product Code
Identification name
7X4-1000.###
Test kit package size
50
Test Package Size
Each pouched kit (3001-3217
Identification name
7X4-1001.###
Test kit package size
250
Test Package Size
Each pouched kit (3001-3217
Identification name
7X4-2001.###
Test kit package size
200
Test Package Size
Each boxed kit (7X4-2001U
Identification name
3001-3217.###
Test kit package size
1
Test Package Size
• 1 Divided Pouch (3001-3217) with o a single-use test device, o a preservative and o a developer solution vial containing 0