Thanks Ted. I jumped right to the EUA authorization list for the serology tests and read the EUA letters for those with "Lateral Flow, Fingerstick Whole Blood." Partly because that was where the Xiamen test was and how it was described. (And of course they use gold particles.) I had no way of knowing for sure if any of the EUA's I reviewed covered the QD test advertised on the Medek website and that is why I used "might just be."
I'll go back and screen the quantitative ones. According to the Medek page the test has authorization, so I'd assume it must be on the list.
Device: MAGLUMI 2019-nCoV IgM/IgG Company: Shenzhen New Industries Biomedical Engineering Co., Ltd. Indication: Qualitative detection and differentiation of immunoglobulin (IgM) and immunoglobulin G (IgG) to SARS-CoV-2 in human serum and serum in separating gel tubes (SST) using the MAGLUMI 2000 series fully-automated chemiluminescence immunoassay analyzer. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories