Ortho Clinical Diagnostics Reagent Kit Vitros® Antibody Test Anti-SARS-CoV-2 Total For use with Vitro ECi / ECiQ (Available End of May) / Vitros 3600 / 5600 / XT7600 100 Tests - Each - 6199922-EA

Ortho Clinical Diagnostics Reagent Kit Vitros® Antibody Test Anti-SARS-CoV-2 Total For use with V...

Features

• The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack test is only for use under the Food and Drug Administration's Emergency Use Authorization: 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
• Results are for the detection of total SARS-CoV-2 antibodies; reactive results could occur after infection and can be indicative of acute or recent infection
• Laboratories within the United States and its territories are required to report all reactive results to the appropriate public health authorities
• Non-reactive results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; results must be combined with clinical observations, patient history, and epidemiological information
• The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total test is performed using the VITROS Anti-SARS-CoV-2 Total Reagent Pack and the VITROS Anti-SARS-CoV-2 Total Calibrator on the VITROS ECi/ECiQ/3600 Immunodiagnostic System and the VITROS 5600/XT 7600 Integrated Systems
• Rx ONLY; For in vitro diagnostic and Laboratory Professional use; For emergency authorization use ONLY
• Reagent Pack Contents: (100) Coated Wells, 6 mL Assay Reagent, 16.2 mL Conjugate Reagent