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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
SLI Medical Acceptable Dating: we will ship >= 90 days
Storage Requirements
Keep Frozen
Test Name
SARS-CoV-2 Antigen
Test Type
41116128
UNSPSC Code
3 X 3 mL
Volume
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
