The FDA cleared a CellaVision test that provides differential counts of white blood cells, characterization of red blood cell morphology, and platelet estimations.
The deal comes one week after the Netherlands said it was buying 9.2 million of the tests. The Canadian government is also purchasing 2,172 BD Veritor Plus Systems.
According to some analysts, the selloff in IVD company shares may be an overreaction, and SARS-CoV-2-related testing will be needed for some time in the future.
The order is the first from a European government following CE-IVD mark in September. The firm expects to ship 1.2 million of the assays by mid-November.
Fujirebio Diagnostics got the nod for a chemiluminescent enzyme immunoassay to measure levels of CA 15-3 and manage patients diagnosed with breast cancer.