Ortho Clinical Diagnostics Antibody Test Control Kit Vitros® Anti-SARS-CoV-2 IgG Positive Level /...
| Item Id | 1166248 |
| MF Id# | 6199921 |
| Brand | Vitros® |
| Manufacturer | Ortho Clinical Diagnostics |
| Country of Origin | United Kingdom |
| Application | Control Kit |
| Container Type | Vial |
| For Use With | For use in Monitoring the Performance of the Vitros Immunodiagnostic and Integrated Systems when used for the Determination of IgG Antibodies to SARS-CoV-2 |
| Form | Liquid |
| Levels | Positive Level / Negative Level |
| 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 | 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