Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit Vitros® SARS-CoV-2 Antigen For use with Vitros 3600 Immunodiagnostic System and Vitros 5600 / XT 7600 Integrated Systems 100 Tests6199949
Picture of Reagent Kit Vitros® SARS-CoV-2 Antigen For use with Vitros 3600 Immunodiagnostic System and Vitros 5600 / XT 7600 Integrated Systems 100 Tests6199949

Reagent Kit Vitros® SARS-CoV-2 Antigen For use with Vitros 3600 Immunodiagnostic System and Vitros 5600 / XT 7600 Integrated Systems 100 Tests6199949

Reagent-Kit-Vitros®-SARS-CoV-2-Antigen-For-use-with-Vitros-3600-Immunodiagnostic-System-and-Vitros-5600--XT-7600-Integrated-Systems-100-Tests6199949

SKU #

#1180545

MPN #

6199949

Brand

Ortho Clinical Diagnostics

Stock

In Stock

Quantity

100

Features

REAGENT PACK, VITROS SARS-COV-2 ANTIGEN (100TEST/EA) D/S

$2,145.56 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1180545
Manufacturer # 6199949
Brand Vitros®
Manufacturer Ortho Clinical Diagnostics
Application Reagent Kit
Container Type Well
For Use With For use with Vitros 3600 Immunodiagnostic System and Vitros 5600 / XT 7600 Integrated Systems
Number of Tests 100 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Sample Type Nasopharyngeal Swab Sample
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 Antigen
Time To Results 48 Minute Results
Type Chemiluminescent Immunoassay
UNSPSC Code 41116010
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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
  • The VITROS SARS-CoV-2 Antigen test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures, and proper infection control procedures
  • EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 is terminated under Section 564(b)(2) of the Act or the EUA is revoked under Section 564(g) of the Act
  • 48 Minutes time to first result
  • Reagent pack contains 100 coated wells, 6 mL assay reagent and 16.2 mL conjugate reagent