Ortho Clinical Diagnostics Antibody Test Control Vitros® Anti-SARS-CoV-2 Total Positive Level / N...
| Item Id | 1165646 |
| MF Id# | 6199924 |
| Brand | Vitros® |
| Manufacturer | Ortho Clinical Diagnostics |
| Country of Origin | United Kingdom |
| Application | Control |
| Container Type | Vial |
| For Use With | For use in Monitoring the Performance of Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600 when used for the Determination of Antibodies to SARS-CoV-2 |
| 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 Total |
| Test Type | Antibody Test |
| UNSPSC Code | 41116128 |
| Volume | 3 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
- 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
- VITROS Anti‑SARS-CoV-2 Total Controls 1 and 2 contain: 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)
- VITROS Anti‑SARS-CoV-2 Total Control 2 in addition contains: SARS-CoV-2 antibody; handle as if capable of transmitting infection
- Includes: 3 sets of VITROS Anti-SARS-CoV-2 Total Controls 1 and 2 (human matrix with anti-microbial agent, 1 mL)ARS-CoV-2 Total Control 2 in addition contains: SARS-CoV-2 antibody; handle as if capable of transmitting infection
- Supplied ready-to-use