Webb††This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration WebbReference range: 0.27-0.49 mcg/mL FEU. Cutoff of <0.5 mcg/mL FEU is considered low probability for pulmonary embolism and/or DVT. Any value ≥0.5 mcg/mL FEU suggests the need for further clinical investigation. D-Dimer determinations should always be evaluated in conjunction with clinical and other laboratory findings.

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