Antibody Test Control Kit Vitros® Anti-SARS-CoV-2 IgG Positive Level / Negative Level 6 X 1 mL

Features

• For use under an Emergency Use Authorization (EUA) Only : https:www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
• 42 U.S.C. section 263a
• to perform moderate and high complexity tests Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities The sensitivity of VITROS Anti-SARS-CoV-2 IgG test in early infection is unknown; 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 VITROS Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing antibodies or other possible causes VITROS Anti‑SARS-CoV-2 IgG Controls 1 and 2 contain: SARS-CoV-2 IgG negative plasma obtained from donors who were tested individually and who were found to be negative for hepatitis B surface antigen
• and for antibodies to hepatitis C virus (HCV) and HIV
• using approved methods (enzyme immunoassays VITROS Anti-SARS-CoV-2 IgG Control 2 in addition contains: SARS-CoV2 IgG - no testing method can rule out the risk of potential infection
• handle as if capable of transmitting infection VITROS Anti-SARS-CoV-2 IgG Controls are suitable for use until the expiration date on the carton when stored and handled as specified; do not use beyond the expiration date VITROS Anti-SARS-CoV-2 IgG Control 1 should generate Non-reactive (Negative) results VITROS Anti-SARS-CoV-2 IgG Control 2 should generate Reactive (Positive) results Kit contains: 3 sets of VITROS Anti-SARS-CoV-2 IgG Controls 1 and 2 (human matrix with anti-microbial agent
• 1 mL) Rx ONLY; for in vitro diagnostic and Laboratory Professional use Supplied ready to use