Calibrator Kit Vitros Anti-SARS-CoV-2 IgG For use with VITROS ECi / ECiQ / 3600 Immunodiagnostic Systems and the VITROS 5600 / XT 7600 Integrated Systems Lyophilized
- VITROS Anti-SARS-CoV-2 IgG Quantitative Antibody test is for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2 \n
- Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform high-complexity tests \n
- The VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Calibrators is a chemiluminescent immunoassay test intended for the qualitative and quantitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (EDTA and lithium heparin) \n
- The VITROS Anti-SARS-CoV-2 IgG Quantitative test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2 \n
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities \n
- The sensitivity of VITROS Anti-SARS-CoV-2 IgG Quantitative test in early infection is unknown; negative results do not preclude acute SARS-CoV-2 infection \n
- False positive results for VITROS Anti-SARS-CoV-2 IgG Quantitative test may occur due to cross-reactivity from pre-existing antibodies or other possible causes \n
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus; follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals \n
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E \n
- Calibrator Contents: 2 sets of VITROS Anti?SARS-CoV-2 IgG Quantitative Calibrators 1, 2 and 3 (anti-SARS-CoV-2 IgG in anti-SARS-CoV-2 IgG negative matrix with antimicrobial agent, 1 mL), Lot calibration card, protocol card, (8) calibrator bar code labels
- UNSPSC:
- 41116145
- Brand:
- Vitros
- Manufacturer:
- Ortho Clinical Diagnostics
- Storage requirements:
- requires refrigeration
- Levels:
- level 1 2 3
- Application:
- calibrator kit
- Test type:
- quantitative antibody test
- Product dating:
- mckesson acceptable dating: we will ship >= 30 days
- For use with:
- for use with vitros eci / eciq / 3600 immunodiagnostic systems and the vitros 5600 / xt 7600 integrated systems
- Form:
- lyophilized
- Manufacturer #:
- 6199961
- Test name:
- anti-sars-cov-2 igg
- Mckesson #:
- 1192945