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40 cardboard, book-shaped hinged test cards with test strips, 1 x 7.5 mL extraction reagent bottle with reagent, 40 sterile nasal swabs, 1 positive control swab containing non-infectious recombinant SARS-CoV-2 nucleocapsid antigen, 1 negative control swab, 1 product insert, 1 procedure card: Type: COVID-19 Test: Clia Complexity: Waived
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Dec 16, 2020·The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization …
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