I want to make sure the following detail is about a product...

I want to make sure the following detail is about a product being sold by Atomo, given some previous confusion with test names. I've checked the TGA website, and confirmed the Carestart Rapid Antigen test is sponsored by both Atomo and Pantonic Health. If I have understood correctly, the following post relates to this test. Forgive me, and please correct me, if I am wrong!

An amendment to the FDA approval was granted on 23 August 2021:

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2


Re: EUA210314/S001
Trade/Device Name: CareStart COVID-19 Antigen Home Test
Dated: July 12, 2021
Received: July 13, 2021

Dear Sang Joon Han:

This is to notify you that your request to update the authorized labeling for the CareStart COVID-19 Antigen Home Test with various edits and clarifications, including a new QR code used to access the On/Go Mobile Application and to make those same edits to the authorized brand name labeling, On/Go COVID-19 Antigen Self-Test, is granted.

Upon review, we concur that the information submitted in EUA210314/S001 supports the requested updates for use with the CareStart COVID-19 Antigen Home Test. By submitting this EUA revision for review by the Food and Drug Administration (FDA), you have complied with the Conditions of Authorization stated in the letter authorizing the emergency use of the CareStart COVID-19 Antigen Home Test issued on August 2, 2021.

Sincerely yours...