Home / Clinical Laboratory / Controls / Control / Antibody Test Control Vitros® Anti-SARS-CoV-2 Total Positive Level / Negative Level 3 X 1 mL6199924
Picture of Antibody Test Control Vitros® Anti-SARS-CoV-2 Total Positive Level / Negative Level 3 X 1 mL6199924

Antibody Test Control Vitros® Anti-SARS-CoV-2 Total Positive Level / Negative Level 3 X 1 mL6199924

Antibody-Test-Control-Vitros®-Anti-SARS-CoV-2-Total-Positive-Level--Negative-Level-3-X-1-mL6199924

SKU #

#1165646

MPN #

6199924

Brand

Ortho Clinical Diagnostics

Stock

In Stock

Quantity

100

Features

CONTROL, ANTI SARS COV-2 TOTALPOS/NEG D/S

$311.11 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1165646
Manufacturer # 6199924
Brand Vitros®
Manufacturer Ortho Clinical Diagnostics
Application Control
Container Type Vial
For Use With For use in Monitoring the Performance of Vitros ECi / ECiQ (Available End of May 2020) / Vitros 3600 / 5600 / XT7600 when used for the Determination of Antibodies to SARS-CoV-2
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 Total
Test Type Antibody Test
UNSPSC Code 41116128
Volume 3 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
  • Results are for the detection of total SARS-CoV-2 antibodies; reactive results could occur after infection and can be indicative of acute or recent infection
  • Laboratories within the United States and its territories are required to report all reactive results to the appropriate public health authorities
  • Non-reactive results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; results must be combined with clinical observations, patient history, and epidemiological information
  • VITROS Anti‑SARS-CoV-2 Total Controls 1 and 2 contain: SARS-CoV-2 antibody 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 Total Control 2 in addition contains: SARS-CoV-2 antibody; handle as if capable of transmitting infection
  • Includes: 3 sets of VITROS Anti-SARS-CoV-2 Total Controls 1 and 2 (human matrix with anti-microbial agent, 1 mL)ARS-CoV-2 Total Control 2 in addition contains: SARS-CoV-2 antibody; handle as if capable of transmitting infection
  • Supplied ready-to-use