- FDA approval under progress (Pre-EUA->EUA status updated 5/21/2020)
- FDA EUA Submission Number: PEUA200206->EUA201334
- Received: 3/25/2020->updated to EUA application on 5/21/2020
- Applicant: Good Gene, InC/Cellgenemedix(Distributor)
- Device: GG COVID-19 Real-Time PCR Kit
- US/South Korean patent filed/received
- KFDA approval for export (5/25/2020)
- WHO approval under progress
- Test kits sent and pre-commercial evaluation done all over the world, including USA, Mexico, and Europe.
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