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

$522.00
CONTROL, ANTI SARS COV-2 TOTALPOS/NEG D/S
SKU
1001165646

Product Specifications

SLI Medical#1165646
Manufacturer #6199924
BrandVitros®
ManufacturerOrtho Clinical Diagnostics
Country of OriginUnited Kingdom
ApplicationControl
Container TypeVial
For Use WithFor 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
Is_Active_VendorPositive Level / Negative Level
Is_DSCSASLI Medical Acceptable Dating: we will ship >= 90 days
Is_DiscontinuedRequires Refrigeration
Is_Medical_DeviceAnti-SARS-CoV-2 Total
LevelsAntibody Test
Lot_Tracking_Flag41116128
On_Allocation3 X 1 mL
Product Dating
Storage Requirements
Supplier_ID
Test Name
Test Type
UNSPSC Code
Volume

Features

  • 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
CONTROL, ANTI SARS COV-2 TOTALPOS/NEG D/S
Additional Information
Product NameAntibody Test Control Vitros® Anti-SARS-CoV-2 Total Positive Level / Negative Level 3 X 1 mL
SKU1001165646
Price$522.00
Weight5.25
Featured ProductNo
Manufacturer Sku6199924
UOMEA
ManufacturerVitros®
Short DescriptionCONTROL, ANTI SARS COV-2 TOTALPOS/NEG D/S