Page 33 - Shimadzu Journal vol.9 Issue1

Latest topics 3

Sales of Novel Coronavirus PCR

Testing Reagent Kits

outside Japan Exports Began

Shimadzu Corporation will begin fully rolling out sales of the novel Shimadzu has been manufacturing the reagent kits for research use
coronavirus (SARS-CoV-2) detection reagent kits outside Japan. in Japan since April of last year and then in September obtained
On January 19th, Shimadzu obtained provisional authorization authorization from Japan’s Ministry of Health, Labour and Welfare
from the Singapore Health Sciences Authority (HSA) to sell the kits to manufacture and sell the kits as a drug for in vitro diagnostic use.
and will start exporting the kits to Southeast Asian markets through Shimadzu remains committed to increasing its contribution to pre-
Shimadzu (Asia Pacific) Pte. Ltd., the Asia/Oceania regional head- venting the spread of infections in Japan and throughout the world
quarter, beginning in early February. by offering testing reagents and instruments in the future as well.
Shimadzu expects to produce up to 3,000 kits (for 300,000 tests) per
In the United States, sales started in September of last year for use month for export markets.
in laboratory developed tests (LDT) based on a U.S. Food and
Drug Administration (FDA) emergency use authorization (EUA).
Learn more about Shimadzu’s response
In Austria, sales for use as research reagents started in October and to the COVID-19 pandemic:
preparations are currently underway for exporting the reagents to https://www.shimadzu.com/covid-19/
France, Croatia, and other EU countries.

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