Ortho Clinical Diagnostics Calibrator Kit Vitros® Anti-SARS-CoV-2 IgG 2 X 1 mL For use with Anti-...
| Item Id | 1166247 |
| MF Id# | 6199920 |
| Brand | Vitros® |
| Manufacturer | Ortho Clinical Diagnostics |
| Country of Origin | United Kingdom |
| Application | Calibrator Kit |
| Container Type | Vial |
| For Use With | For use with Anti-SARS-CoV-2 IgG Test on Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600 |
| Form | Liquid |
| Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
| Storage Requirements | Requires Refrigeration |
| Test Name | Anti-SARS-CoV-2 IgG |
| Test Type | Antibody Test |
| UNSPSC Code | 41116145 |
| Volume | 2 X 1 mL |
Features
- The VITROS Anti-SARS-CoV-2 IgG 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
- 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 test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
- At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
- VITROS Anti-SARS-CoV-2 IgG test should not be used to diagnose acute SARS-CoV-2 infection
- VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator is a chemiluminescent immunoassay test intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum
- VITROS Anti‑SARS-CoV-2 IgG Calibrator is suitable for use until the expiration date on the carton when stored and handled as specified; do not use beyond the expiration date
- The VITROS Anti‑SARS-CoV-2 IgG test uses 20 μL of calibrator for each determination
- VITROS Anti‑SARS-CoV-2 IgG Calibrator is supplied ready to use