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Health and Medical News

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


<p>Latest News from the World Health Organization (WHO).&nbsp;</p><p>Mission of World Health Organization:&nbsp;Our goal is to build a better, healthier future for people all over the world. Working through offices in more than 150 countries, WHO staff work side by side with governments and other partners to ensure the highest attainable level of health for all people.</p>