CorDx Granted CE Mark for Two Monkeypox Diagnostic Tests
Diagnostics enable the detection of the monkeypox virus in humans
Excerpt from the Press Release:
SAN DIEGO, Aug. 18, 2022 /PRNewswire/ — CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices, was recently granted a CE Mark certificate for two of the company’s monkeypox diagnostic tests.
The CE Mark, granted on May 23, 2022, enables CorDx to market the tests in the European Union (EU).
The first test, the Monkeypox Virus Fluorescence PCR Kit, is used for the qualitative detection of monkeypox virus nucleic acid in human rash exudates/whole blood/plasma samples. It is also used for clinical auxiliary diagnosis and treatment.
The second test, the Monkeypox Virus IgM/IgG Ab Test, is a lateral flow chromatographic immunoassay used for the qualitative detection of monkeypox virus IgM and IgG antibodies in human whole blood/serum/plasma samples.
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