Certifications and Regulatory Status
The diagnostic kits on this site are manufactured in Korea by Goodgene, Inc., our manufacturing partner. CellGeneMedix LLC is Goodgene's U.S. distribution partner. The certifications and approvals below are held by Goodgene, Inc.
U.S. regulatory status
None of these products is authorized or cleared by the U.S. Food and Drug Administration (FDA). They are not available for clinical use in the United States.
- 2020Emergency Use Authorization (EUA) request submitted to the FDA for the GG COVID-19 QuadPlex Multiplex PCR (not authorized)
- 2021Pre-EUA submission to the FDA for PCR testing by CellGeneMedix
- 2022Pre-EUA submission to the FDA for antigen testing by CellGeneMedix
Quality management certifications
Goodgene, Inc., since 2020 (year of certification):
- 2020GMP-certified manufacturing facility
- 2021ISO 9001:2015 and ISO 13485:2016
- 2022ISO 13485 for immunological in vitro diagnostic devices (Class 4)
Product approvals outside the United States (since 2020)
Korea: MFDS (formerly KFDA)
- 2020Manufacturing permission for COVID-19 PCR medical devices
- 2020GG COVID-19 QuadPlex Multiplex PCR
European Union: CE mark
- 2020GG COVID-19 RT-PCR kit
- 2022Good Ag COVID-19 Antigen Rapid Test
For patents and patent applications, see Patents. For product details, see Diagnostic Products.
Certificates are available on request: info@cellgenemedix.com.
