Calibrator Access® SARS-CoV-2 IgG II 6 X 2 mL For use with Access Family of 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