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

$518.77
CONTROL, VITROS SARS-COV-2 ANTIGEN 2 LEVELS 3X3ML D/S
SKU
1001180547

Product Specifications

SLI Medical#1180547
Manufacturer #6199943
BrandVitros®
ManufacturerOrtho Clinical Diagnostics
Country of OriginUnited Kingdom
ApplicationControl Kit
Container TypeVial
For Use WithFor 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
FormLyophilized
Is_Active_Vendor2 Levels
Is_DSCSASLI Medical Acceptable Dating: we will ship >= 90 days
Is_DiscontinuedKeep Frozen
Is_Medical_DeviceSARS-CoV-2 Antigen
Levels41116128
Lot_Tracking_Flag3 X 3 mL
On_Allocation
Product Dating
Storage Requirements
Supplier_ID
Test Name
Test Type
UNSPSC Code
Volume

Features

  • 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)
CONTROL, VITROS SARS-COV-2 ANTIGEN 2 LEVELS 3X3ML D/S
Additional Information
Product NameImmunoassay Control Kit Vitros® SARS-CoV-2 Antigen 2 Levels 3 X 3 mL
SKU1001180547
Price$518.77
Weight5.25
Featured ProductNo
Manufacturer Sku6199943
UOMEA
ManufacturerVitros®
Short DescriptionCONTROL, VITROS SARS-COV-2 ANTIGEN 2 LEVELS 3X3ML D/S