SF - In Vitro Diagnostic Product
Product Details
WHO Product ID
0244-055-00
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 serology
Regulatory Version Submitted To PQ
Directive 98/79/EC: Full quality assurance certificate, Annex IV.3
Applicant organization
OraSure Technologies, Inc.
220 East First Street
Bethlehem,
18015
United States of America
Pathogen
HCV
Specimen Type
Oral fluid
Plasma
Serum
Whole blood (capillary)
Whole blood (venous)
Product Code
Identification name
1001-0270
Test kit package size
25
Test Package Size
25 x Divide test pouch, 5 x reusable test stands, 25 x collection loops, and 1 x IFU
Identification name
1001-0274
Test kit package size
100
Test Package Size
100 x Divided test pouch:
Contains OraQuick HCV Rapid Antibody Test plus Absorbent Packet and OraQuick HCV Developer Solution, 10 x reusable test stands, 100 x collection loops, 1 x IFU
Contains OraQuick HCV Rapid Antibody Test plus Absorbent Packet and OraQuick HCV Developer Solution, 10 x reusable test stands, 100 x collection loops, 1 x IFU
IVD Manufacturing Site(s)
OraSure Technologies - North Facility
1745 Eaton Ave
Bethlehem,
18015
United States of America
Pacific Biotech Co., Ltd_site 1
42 Moo 4, Chailanglub Rd, Napa
Muang, Petchaboon,
6700