Want to learn more about BGI’s Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2?
BGI, the largest genomics company in the world, has chosen Charter Oak Development - Odell International as an Authorized Distributor. Attached are the corresponding FDA EUA documents.
Products from BGI that are related to COVID-19 are regulated and only available to clinical and diagnostic laboratories. If you are a consumer looking for a COVID-19 test, please see your health care provider for medical advice. For additional COVID-19 information, visit the CDC or WHO sites.
In the United States:
– This test has not been FDA cleared or approved;
– This test has been authorized by FDA under an EUA for use by authorized laboratories;
– This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
– This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.
Coming Soon!
Not FDA EUA approved. This is the first Covid Rapid Home Test with Full FDA Approval. Made both in the USA and Germany.
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