Dakshidin Corporation (DKSC)

[stervc]

DKSC**FDA Allowed COVID-19 Rapid Testing Kits...

I see the now. These testing kits for COVID-19 looks to be the real deal for DKSC through its wholly owned subsidiary, White Chapel Holdings, as it says that they can deliver results within 15 minutes with no instrumentation required:

https://whitechapelholdingsusa.com/ppe/
(Go down to the 4th button that says "Download" and click where it says "View Rapid Testing Kits")

You will then see this below, but make sure to see that the FDA Registration Number is 3009414546 which is the number that is confirmed within the following PR confirming that these COVID-19 Rapid Testing Kits have been submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and that the FDA is currently allowing their test to be made available in the U.S. as the agency reviews its EUA application. The following two slides will confirm that Proven Pharma is the Exclusive Distributor of the Clungene® SARS-CoV-2 IgG/IgM Rapid Serology Tests that exist within DKSC through its wholly owned subsidiary, White Chapel Holdings:

These COVID-19 Rapid Testing Kits have been approved by the FDA to be used in the US. Read from the PR below:

https://finance.yahoo.com/news/proven-pharma-named-exclusive-distributor-140700389.html
The test has been submitted to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and is awaiting approval. The FDA is currently allowing the test to be made available in the U.S. as the agency reviews its EUA application.

The FDA is allowing Clungene® SARS-CoV-2 IgG/IgM Rapid Serology Test to be made available under its new policy dated May 4, 2020. (Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency). As required, the completed EUA template and associated documentation were submitted on May 15, 2020 to the FDA. The submission (EUA#201121) included updated validation reports and additional clinical data. Clungene's establishment registration & device number on the FDA's website is 3009414546.

The test, which should be administered by healthcare professionals, produces Rapid Point of Care results in 15 minutes from whole blood drawn with a finger prick. The diagnostic cassette does not require laboratory equipment or instrumentation, and users do not need to ship the sample to a lab. The manufacturer has performed two clinical studies of the test, both of which were submitted to the FDA, and Proven Pharma is in the process of conducting a third trial in the U.S.

Proven Pharma has distributed Hangzhou Clongene Biotech products in the U.S. since 2018. Proven Pharma has performed multiple site visits of the Hangzhou Clongene Biotech facilities for quality assurance and supply chain efficiencies. Founded in 2004, Clongene is registered to sell 24 products in the U.S., according to the FDA, including the Clungene® SARS-CoV-2 Virus (COVID-19) IgG/IgM Rapid Test Cassette. ...

Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-health-emergency-revised

Hangzhou Clongene Biotech Co., Ltd. has a 16 year history of Rapid Test manufacturing, with 23 FDA 510(k) cleared Rapid Tests available in the US.*

http://en.clongene.com/uploads/20200628/95c4e3dbf06daa97f0b83549bb5bf820.pdf

v/r
Sterling