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S. Korean-made test kits get preliminary FDA approval

All News 18:46 March 28, 2020

SEOUL, March 28 (Yonhap) -- Three South Korean-made COVID-19 test kits have obtained a preliminary approval from the U.S. Food and Drug Administration (FDA), the foreign ministry said Saturday.

The initial FDA approval will allow South Korean manufacturers of the three virus test kits to sell the products in the United States, where confirmed coronavirus cases have surpassed 100,000, an official at the Ministry of Foreign Affairs said over the phone.

The ministry expected the approval to accelerate exports of the test kits to U.S. markets.

This file photo taken Feb. 6, 2020, shows COVID-19 testing reagents produced by a South Korean company. (Yonhap)

In a phone conversation with President Moon Jae-in on Tuesday, U.S. President Donald Trump expressed hope that South Korea could provide medical equipment support to help contain the spread of the respiratory illness in the U.S.

Moon replied that his government would provide "maximum support" if available as the two leaders discussed bilateral cooperation in the fight against the novel coronavirus pandemic.

He then pointed out that approval by the FDA might be required. In response, Trump said he would make immediate action for that "within today."

South Korea has been widely lauded for its effective and swift response to the spread of the virus, taking advantage of its advanced testing capabilities. It has been exporting test kits to a number of countries.


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