Home / Clinical Laboratory / Controls / Control Kit / Control Kit Vitros® SARS-CoV-2 Antigen 2 Levels 3 X 3 mL6199943
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Control Kit Vitros® SARS-CoV-2 Antigen 2 Levels 3 X 3 mL6199943

Control-Kit-Vitros®-SARS-CoV-2-Antigen-2-Levels-3-X-3-mL6199943

SKU #

#1180547

MPN #

6199943

Brand

Ortho Clinical Diagnostics

Stock

In Stock

Quantity

100

Features

CONTROL, VITROS SARS-COV-2 ANTIGEN 2 LEVELS 3X3ML D/S

$311.11 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1180547
Manufacturer # 6199943
Brand Vitros®
Manufacturer Ortho Clinical Diagnostics
Application Control Kit
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 Name SARS-CoV-2 Antigen
UNSPSC Code 41116128
Volume 3 X 3 mL
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  • 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)