ViraxClear Receives FDA Facility Registration and Device Listing
2020年8月10日 - 9:00PM
Global Care Capital Inc. (CSE:
HLTH, FRANKFURT:
L6V1) (the
“
Company” or “
Global Care”) a
global investment company which engages in early stage investment
opportunities in private and public companies, is pleased to
announce that its portfolio company, ViraxClear, through its joint
venture with Shanghai Biotechnology Devices Ltd.
(“
SBD”) has on August 3rd, 2020, received
confirmation of its United States Food and Drug Administration
(“
FDA”) Facility Registration and Device Listing.
James Foster, CEO of ViraxClear, states that
“This represents an important step in our expansion plans; with a
view to acting as a Foreign Exporter for our products to The US
Market. We have listed the products we deem most in demand in the
US: KN95 masks, 3-ply masks and infrared thermometers and will be
pursuing next steps with initial importers for the US market.”
FDA Registration
Establishments that are involved in the
production and distribution of medical devices intended for
commercial distribution in the United States (U.S.), including
those that are imported for export only, are required to register
with the FDA. Most establishments that are required to register are
also required to list the devices and the activities performed on
those devices at that establishment. A Foreign Exporter
exports or offers for export to the United States (U.S.), a device
manufactured, prepared, propagated, compounded, or processed in a
foreign country, including devices originally manufactured in the
United States.
The Devices
The ViraxCare brand, website: www.viraxcare.com,
focuses on offering PPE for businesses to minimise the risks of
their employees returning to work. These are aimed at all employees
regardless of whether they work in an office, a construction site,
a restaurant or a clinic. The following devices have been FDA
registered, with a view to supply to The US market:
KN95 Masks - ViraxClear has
developed its own range of KN95, FDA Registered and CE marked
masks, which may be comfortably worn for hours.
https://www.globenewswire.com/NewsRoom/AttachmentNg/f80bcdc2-0af3-49ba-be8a-09b4fd3e7f8f
Disposable 3 Ply Masks -
ViraxClear has developed its own range of FDA Registered and CE
marked 3-ply disposable masks, which are particularly helpful
travelling to and from work.
https://www.globenewswire.com/NewsRoom/AttachmentNg/ef506f15-b27e-47df-97ac-0a44e8008395
Infrared Thermometer - The
thermometers do not require contact with a person and can swiftly
measure temperature from 1cm-5cm from the forehead. These are
particularly useful for use in public places like a hotel, airport,
factory or office. These are battery-operated, handy and easy to
use thermometers, which do not require any trained technicians.
Whilst they are by no means definitively accurate in the detection
of COVID-19, they are widely being used across the world to detect
potential symptomatic COVID-19 carriers.
https://www.globenewswire.com/NewsRoom/AttachmentNg/b4a34289-049d-478a-be38-2737a3805b01
About ViraxClear
ViraxClear focuses on commercializing novel
products that address significant healthcare needs with a
specific target on the novel coronavirus (COVID-19). The
company’s main focus is marketing its ViraxClear Rapid IgM-IgG
Combined Antibody Test and ViraxCare PPE. The ViraxClear Rapid
IgM-IgG Combined Antibody Test for COVID-19 is a lateral flow
immunoassay used to qualitatively detect both early and late
marker IgG/IgM antibodies. ViraxCare is aimed at minimizing at-work
risks by supplying PPE for employees and innovative products and
devices which monitor potential viral outbreaks.
Website:
http://www.viraxclear.com
http://www.viraxcare.com
info@viraxclear.com
About Global Care
Global Care Capital is a global investment
company which specializes in providing early stage financing to
private and public companies. The Company engages in new, early
stage investment opportunities in previously underdeveloped assets
and obtaining positions in early stage investment opportunities
that adequately reflect the risk profile.
Website:
www.globalcarecapital.com
GLOBAL CARE CAPITAL
INC.:
Company Contact:
Alex Somjen, President & CEO
416-319-5744
info@globalcarecapital.com
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