Antibody Test Control Set Access® SARS-CoV-2 IgG II 2 Levels 6 X 4 mL

Features

• This test has not been reviewed by the FDA
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high or moderate complexity tests
• For U.S.A. only, Federal law restricts this device to sale and distribution by or on the order of a physician, or to a clinical laboratory; and use is restricted to by or on the order of a physician
• Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
• Negative results do not preclude acute SARS-CoV-2 infection
• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E
• QC1-QC2, 4 mL/vial, 3 vials each level

More Information

• Access SARS-CoV-2 IgG II Quality Control IFU