ViraxClear Receives FDA Facility Registration and Device Listing
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VANCOUVER, British Columbia, Aug. 10, 2020 (GLOBE NEWSWIRE) -- 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: , 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.
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.
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.
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.
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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.
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GLOBAL CARE CAPITAL INC.:
Company Contact:
Alex Somjen, President & CEO
416-319-5744
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Forward-Looking Information: This news release includes certain statements that may be deemed “forward-looking statements”. The use of any of the words “anticipate”, “continue”, “estimate”, “expect”, “may”, “will”, “would”, “project”, “should”, “believe” and similar expressions are intended to identify forward-looking statements. Although the Company believes that the expectations and assumptions on which the forward-looking statements are based are reasonable, undue reliance should not be placed on the forward-looking statements because the Company can give no assurance that they will prove to be correct. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. These statements speak only as of the date of this News Release. Actual results could differ materially from those currently anticipated due to a number of factors and risks including various risk factors discussed in the Company’s disclosure documents which can be found under the Company’s profile on
