Please Read The Following FDA Guidance Before Completing a Purchase of Testing Kits
Current information on COVID-19 for healthcare providers is available at CDC’s webpage, Information for Healthcare Professionals (see links provided in “Where can I go for updates and more information” section).
• Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit can be ordered by healthcare providers to test human serum, plasma (heparin, dipotassium EDTA, or sodium citrate) and venipuncture whole blood (heparin, dipotassium EDTA, or sodium citrate) to detect if there has been an adaptive immune response to COVID-19, indicating recent or prior infection.
• Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit should not be used to diagnose or exclude acute infection and should not be used as the sole basis for treatment or patient management decisions. Direct testing for SARS-CoV-2 should be performed if acute infection is suspected.
• Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests.
• Please refer to the Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit instructions for use for additional information.
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