Calibrator Set Access® SARS-CoV-2 IgG 2 mL For Access Family of Immunoassay Systems Only

Features

• This product has been authorized by FDA under an EUA for use by laboratories certified under CLIA, that meet requirements to perform moderate or high complexity tests: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
• The Access SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
• For Calibrating the Access SARS-CoV-2 IgG Assay for the in vitro Qualitative Detection of SARS-CoV-2 IgG Antibodies in Human Serum 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
• False positive results for the Access SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes
• Refer to calibration card for exact concentrations
• For In Vitro Diagnostic Use
• Rx Only
• Access SARS-CoV-2 IgG calibrators are provided as: negative and positive

More Information

• Access SARS-CoV-2 IgG FDA EUA
• Access SARS-CoV-2 IgG Calibrator IFU
• Access SARS-CoV-2 IgG Healthcare Providers Fact Sheet
• Access SARS-CoV-2 IgG Recipients Fact Sheet