-
,for, Item ID-
- #1180547
- Ortho Clinical Diagnostics #6199943
Immunoassay Control Set Vitros® SARS-CoV-2 Antigen 2 Levels 3 X 3 mL
CONTROL, VITROS SARS-COV-2 ANTIGEN 2 LEVELS 3X3ML D/S
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Features
- The Vitros SARS-CoV-2 Antigen Reagent Pack used in combination with the Vitros SARS-CoV-2 Antigen Calibrator is for use under an FDA EUA only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate or high complexity tests
- The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen test is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within one to six days of the onset of symptoms using the VITROS 3600 Immunodiagnostic System and the VITROS 5600/XT 7600 Integrated Systems
- More …
Product Details Email
Product Specifications
McKesson # | 1180547 |
---|---|
Manufacturer # | 6199943 |
Brand | Vitros® |
Manufacturer | Ortho Clinical Diagnostics |
Country of Origin | United Kingdom |
Application | Control Set |
Container Type | Vial |
For Use With | For use in Monitoring the Performance of the VITROS 3600 Immunodiagnostic System and the VITROS 5600 / XT 7600 Integrated Systems for the Qualitative Detection of the SARS-CoV-2 Nucleocapsid Antigen |
Form | Lyophilized |
Levels | 2 Levels |
Product Dating | McKesson Acceptable Dating: we will ship >= 90 days |
Storage Requirements | Keep Frozen |
Test Category | Respiratory |
Test Name | SARS-CoV-2 Antigen |
Test Type | Immunoassay |
UNSPSC Code | 41116128 |
Volume | 3 X 3 mL |
Features
- The Vitros SARS-CoV-2 Antigen Reagent Pack used in combination with the Vitros SARS-CoV-2 Antigen Calibrator is for use under an FDA EUA only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate or high complexity tests
- The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen test is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasopharyngeal (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within one to six days of the onset of symptoms using the VITROS 3600 Immunodiagnostic System and the VITROS 5600/XT 7600 Integrated Systems
- Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status; positive results do not rule out bacterial infection or co-infection with other viruses
- Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
- Negative results from patients with symptom onset outside of one to six days should be treated as presumptive
- Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19
- VITROS SARS-CoV-2 Antigen Control 1 should generate Non-reactive results
- VITROS SARS-CoV-2 Antigen Control 2 should generate Reactive results
- Includes: 3 sets of VITROS SARS-CoV-2 Antigen Controls 1 and 2 (recombinant SARS-CoV-2 nucleocapsid antigen in buffer with bovine serum albumin and antimicrobial agent, 3 mL)
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