KUALA LUMPUR: MyEG Services Bhd (MyEG) said its Covid-19 rapid test kit has been qualified for emergency use by the US Food and Drug Administration (FDA), paving the way for the sale of the kit in the US, where the number of positive cases has surpassed 33,000, with 417 deaths.
Nonetheless, in Malaysia, the rapid test kit is pending approval and certification by the ministry of health (MoH).
The company earlier said the kit had already been approved by health authorities in China and Europe, where they are already being used widely.
MyEG said the test kit, developed by an unnamed “reputable” Chinese biomedical company, has been approved by the FDA under a policy to accelerate detection and diagnosis during public health emergencies.
“The authorisation by the FDA for the test kits is in addition to the European CE mark, which certifies conformity with health, safety, and environmental protection standards, obtained earlier,” it said in a statement yesterday.