Calibrator Set Access® SARS-CoV-2 IgG II 6 X 2 mL For Access Immunoassay Systems

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
• The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human serum, serum separator tubes and plasma (heparin, EDTA, citrate) for use on the Access Family of Immunoassay Systems only
• 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. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary
• 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
• The Access SARS-CoV-2 IgG II Calibrators are provided at six levels – zero and approximately 5.0, 25.0, 100, 200, and 450 AU/mL

More Information

• Access SARS-CoV-2 IgG II Calibrator IFU