News

News

FDA approval under progress (Pre-EUA->EUA status updated 5/21/2020) FDA EUA Submission Received 3/25/2020 FDA EUA updated to EUA application on 5/21/2020 Applicant: Good Gene, InC(Manufacturer) /Cellgenemedix(Distributor) Device: GG COVID-19 Real-Time PCR Kit US patent filed/received (USPTO: 63022403/confirmation: 7824) South Korean patent filed/received (2020-0055198) Korean KFDA approval for manufacture and export (5/25/2020) WHO approval under progress Test kits sent and pre-commercial evaluation done...
All countries
45,604,615
Total confirmed cases
Updated on October 30, 2020 4:29 pm
Italy
647,674
Total confirmed cases
Updated on October 30, 2020 4:29 pm
Spain
1,238,922
Total confirmed cases
Updated on October 30, 2020 4:29 pm
Iran
604,952
Total confirmed cases
Updated on October 30, 2020 4:29 pm
Germany
512,720
Total confirmed cases
Updated on October 30, 2020 4:29 pm

Frequently Asked Questions

List of US and Korean/international patents

This list entails the scope of patents that Good Gene Korea (www.goodgenekorea.com; Cellgenemedix's manufacturer and mother company) has held over the years. The most recent...

Lower respiratory specimens

Lower respiratory tract specimens (1)Bronchoalveolar lavage, tracheal aspirate -2 to 3 mL should be collected in a sterile, leak-proof, screw-cap sputum collection cup or sterile, dry...

KFDA approval / US patent

Korean FDA approved for export and manufacture US patent filed ISO certification stadards achieved for the production process

SOP (Instruction Manual) for GG Quadplex Real Time RT-PCR kit

The GG COVID-19 Quadplex Real-Time RT-PCR test is to be used with the following Real-Time PCR machines and associated software (additional machines may contact...

GoodGene COVID-19 QuadPlex RT-PCR

The GoodGene COVID-19 QPlex RT-PCR Kit was designed to detect open reading frame (ORF1ab), RdRP, and nucleoprotein (N) based on the genomic database of...

Purchase and Delivery

Purchase and Delivery Reagents: (1) GG Primer/probes (2) GG Postive (ORF, RdRP and N gene of COVID-19) and internal controls (3) Reverse transcription (RT)-PCR premix (one step reverse...