Home / Clinical Laboratory / Controls / Control Kit / Antibody Test Control Kit Vitros® Anti-SARS-CoV-2 IgG Positive Level / Negative Level 6 X 1 mL6199921
Picture of Antibody Test Control Kit Vitros® Anti-SARS-CoV-2 IgG Positive Level / Negative Level 6 X 1 mL6199921

Antibody Test Control Kit Vitros® Anti-SARS-CoV-2 IgG Positive Level / Negative Level 6 X 1 mL6199921

Antibody-Test-Control-Kit-Vitros®-Anti-SARS-CoV-2-IgG-Positive-Level--Negative-Level-6-X-1-mL6199921

SKU #

#1166248

MPN #

6199921

Brand

Ortho Clinical Diagnostics

Stock

In Stock

Quantity

100

Features

CONTROL, VITROS ANTI-SARS-COV-2 IGG AB POS/NEG D/S

$311.11 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1166248
Manufacturer # 6199921
Brand Vitros®
Manufacturer Ortho Clinical Diagnostics
Application Control Kit
Container Type Vial
For Use With For use in Monitoring the Performance of the Vitros Immunodiagnostic and Integrated Systems when used for the Determination of IgG Antibodies to SARS-CoV-2
Form Liquid
Levels Positive Level / Negative Level
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Requires Refrigeration
Test Name Anti-SARS-CoV-2 IgG
Test Type Antibody Test
UNSPSC Code 41116145
Volume 6 X 1 mL
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  • For use under an Emergency Use Authorization (EUA) Only : https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. section 263a, to perform moderate and high complexity tests
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • The sensitivity of VITROS Anti-SARS-CoV-2 IgG test in early infection is unknown; negative results do not preclude acute SARS-CoV-2 infection - if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
  • False positive results for VITROS Anti-SARS-CoV-2 IgG test may occur due to cross-reactivity from pre-existing antibodies or other possible causes
  • VITROS Anti‑SARS-CoV-2 IgG Controls 1 and 2 contain: SARS-CoV-2 IgG negative plasma obtained from donors who were tested individually and who were found to be negative for hepatitis B surface antigen, and for antibodies to hepatitis C virus (HCV) and HIV, using approved methods (enzyme immunoassays
  • VITROS Anti-SARS-CoV-2 IgG Control 2 in addition contains: SARS-CoV2 IgG - no testing method can rule out the risk of potential infection, handle as if capable of transmitting infection
  • VITROS Anti-SARS-CoV-2 IgG Controls are suitable for use until the expiration date on the carton when stored and handled as specified; do not use beyond the expiration date
  • VITROS Anti-SARS-CoV-2 IgG Control 1 should generate Non-reactive (Negative) results
  • VITROS Anti-SARS-CoV-2 IgG Control 2 should generate Reactive (Positive) results
  • Kit contains: 3 sets of VITROS Anti-SARS-CoV-2 IgG Controls 1 and 2 (human matrix with anti-microbial agent, 1 mL)
  • Rx ONLY; for in vitro diagnostic and Laboratory Professional use
  • Supplied ready to use