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Gov't reconfirms S. Korean-made virus test kits can be exported to U.S.

All News 15:23 March 30, 2020

By Kim Seung-yeon

SEOUL, March 30 (Yonhap) -- The foreign ministry reconfirmed Monday that three South Korean coronavirus test kits can be exported to the United States as they were given pre-emergency use authorization numbers from the U.S. Food and Drug Administration (FDA).

On Saturday, the foreign ministry issued a press release that the three unidentified companies have gained preapproval in the FDA's emergency use authorization (EUA) process and that their diagnostic devices can be sold in the U.S. market.

But the announcement created confusion as it turned out that none of the test kit manufacturers that applied for EUA approval knew about the authorization. Some newspapers accused the ministry of making the announcement in a hurried manner to show it is the result of President Moon Jae-in's diplomacy toward the U.S.

The release came just days after Moon spoke by phone with U.S. President Donald Trump and called for FDA approval of South Korean test kits.

"The interim approval has been given, as the FDA has granted the authorization numbers for pre-emergency use," a senior foreign ministry official told reporters on condition of anonymity.

Gov't reconfirms S. Korean-made virus test kits can be exported to U.S. - 1

"There is no problem with exports to the U.S. It is for certain that the export is possible," another ministry official familiar with the matter said.

The government plans to officially inform the manufacturers of the interim EUA approval later in the day, the official added. The White House has also confirmed that the U.S. government will soon proceed with the procurement process, according to Seoul's foreign ministry.

A total of 12 Korean test kit makers have applied for the pre-EUA approval and more companies are expected to gain the approval given the high demand for the devices amid the urgency of the outbreak situation in the U.S., officials said.

The coronavirus caseload in the U.S. has topped 142,000, making it the most infected country in the world, with at least 2,400 deaths.

Early last week, U.S. President Donald Trump spoke by phone with Moon and asked for Korea to provide medical devices to help contain the spread of the novel virus. Moon promised "maximum support" within the confines of not disrupting the local demand.

South Korea has been widely lauded for an effective response system against the virus with its advanced testing capabilities. The foreign ministry has said that more than 100 countries have expressed a desire to secure quarantine products from Korea either via import or humanitarian aid.


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