Company Product Description Indication Status
Baebies Inc., of Durham, N.C. Assays on Seeker Newborn screening assays Galactosemia and biotinidase deficiency Has met all requirements for CE mark under the IVD Directive
Letsgetchecked, of New York and Dublin Sure-track Test At-home polymerase chain reaction nasal swab test Coronavirus at-home testing Received emergency use authorization from the U.S. FDA

Notes

For more information about individual companies and/or products, see Cortellis.

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