PMCB Receives Mark for Licensed COVID-19 Tests
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Posted On: 07/29/2020 9:50:25 AM
PMCB Receives Mark for Licensed COVID-19 Tests
PharmaCyte Biotech Receives CE Mark for Licensed COVID-19 Molecular TestsPress Release | 07/29/2020
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that the COVID-19 Molecular tests it has licensed from Hai Kang Life Corporation Limited (Hai Kang) have received the CE mark. The CE mark was given to the RT-PCR and ERT-PCR tests.
The Declaration of Conformity for the COVID-19 tests confirms that the tests meet the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the product as an IVD in the European Union member countries.
The Chief Executive Officer of PharmaCyte Biotech, Kenneth L. Waggoner, stated, “The CE mark will now allow the tests to be marketed in the European Union. We are also working with Hai Kang to update our EUA submission with the Pool Testing Protocol released by the FDA in early June.”
PharmaCyte Biotech Receives CE Mark for Licensed COVID-19 Molecular TestsPress Release | 07/29/2020
PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box®, announced today that the COVID-19 Molecular tests it has licensed from Hai Kang Life Corporation Limited (Hai Kang) have received the CE mark. The CE mark was given to the RT-PCR and ERT-PCR tests.
The Declaration of Conformity for the COVID-19 tests confirms that the tests meet the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the product as an IVD in the European Union member countries.
The Chief Executive Officer of PharmaCyte Biotech, Kenneth L. Waggoner, stated, “The CE mark will now allow the tests to be marketed in the European Union. We are also working with Hai Kang to update our EUA submission with the Pool Testing Protocol released by the FDA in early June.”
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