Ortho Clinical Diagnostics Calibrator Vitros® Anti-SARS-CoV-2 Total 2 X 1 mL For use with Anti-SA...
| Item Id | 1165645 |
| MF Id# | 6199923 |
| Brand | Vitros® |
| Manufacturer | Ortho Clinical Diagnostics |
| Country of Origin | United Kingdom |
| Application | Calibrator |
| Container Type | Vial |
| For Use With | For use with Anti-SARS-CoV-2 Total Reagent Pack Test on Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600 |
| Form | Ready-to-Use |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Storage Requirements | Requires Refrigeration |
| Test Name | Anti-SARS-CoV-2 Total |
| Test Type | Antibody Test |
| UNSPSC Code | 41116128 |
| Volume | 2 X 1 mL |
Features
- For use under the Food and Drug Administration's Emergency Use Authorization 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
- 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
- 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
- Rx ONLY; For in vitro diagnostic and Laboratory Professional use; For emergency authorization use ONLY
- Calibrator contains: SARS-CoV-2 antibody 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)
- Calibrator contents: 2 vials of VITROS Anti‑SARS-CoV-2 Total Calibrator (anti-SARS-CoV-2 in anti-SARS-CoV-2 negative human plasma with antimicrobial agent, 1 mL)
- The VITROS Anti‑SARS-CoV-2 Total test uses 80 μL of calibrator for each determination