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HIV Rapid Tests: progress of the active applications in the prequalification of IVDs assessment pipeline
Product name
Product code(s)
Manufacturer name
Dossier
review
On-site
inspection
Laboratory
evaluation
Genedia HIV1/2 Rapid 3.0 Plus
749
Green Cross Medical Science Corp.
Atomo HIV Self Test
ARST001
Atomo Diagnostics Pty Ltd
One Step HIV1/2 Whole Blood/Serum/Plasma Test
W006-C4P2 and W006-C4P2-F
Guangzhou Wondfo Biotech Co., Ltd.
First Response HIV 1-2.O Card Test Version 2.0
PI05FRC25, PI05FRC30, PI05FRC50, PI05FRC60,
PI05FRC100
Premier Medical Corporation Limited
ONE STEP Anti-HIV (1&2) Test
ITP02152-TC40, ITP02152-TC25, ITP02153-TC40,
ITP02153-TC10
InTec Products, Inc
abridged
assessment
S
R
information requested
from manufacturer
in process
stage complete
F
follow-up amendments
Please note: these tables are updated regularly; while every attempt is made to provide current data, the most recent information might not be
reflected. This table is intended only as an update on progress and does not reflect a final decision on prequalification. This table should not be used to
inform procurement.mation may not yet be reflected here.
Last update: 29 August 2018
http://www.who.int/diagnostics_laboratory/pq_status/en/index.html
S
scheduled;
date confirmed