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Tank Style Highlighter Value Pack, Fluorescent Yellow Ink, Chisel Tip, Yellow Barrel, 36/Box
Calibrator Kit Vitros® Anti-SARS-CoV-2 Total N Antibody For VITROS ECi / ECiQ / 3600 Immunodiagnostic Systems and the VITROS 5600 / XT 7600 Integrated Systems Lyophilized
$148.22
CALIBRATOR, VITROS SARS-COV-2 TOTAL N AB (2/PK) D/S
SKU
2001192948
License which authorizes the purchase of regulated products is required
For VITROS ECi / ECiQ / 3600 Immunodiagnostic Systems and the VITROS 5600 / XT 7600 Integrated Systems
Form
Lyophilized
Product Dating
SLI Medical Acceptable Dating: we will ship >= 30 days
Storage Requirements
Requires Refrigeration
Test Name
Anti-SARS-CoV-2 Total N Antibody
Test Type
Antibody Test
UNSPSC Code
41116145
Features
The Vitros Anti-SARS-CoV-2 Total N Antibody test is only for use under the Food and Drug Administration's Emergency Use Authorization: https:www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-serology-and-other-adaptive-immune-response-tests-sars-cov-2
Testing is limited to 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
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Reagent Pack when used in combination with the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody Calibrators is a chemiluminescent immunoassay test intended for the qualitative detection of total antibody (including IgG
IgA and IgM) to SARS-CoV-2 nucleocapsid protein in human serum and plasma (K2 -EDTA)
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
The sensitivity of VITROS Anti-SARS-CoV-2 Total N Antibody 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 Total N Antibody test may occur due to cross-reactivity from pre-existing antibodies or other possible causes
Negative results do not rule out SARS-CoV-2 infection
particularly in those who have been in contact with the virus
Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains
such as coronavirus HKU1
NL63
OC43
or 229E
Kit contains: 2 vials of VITROS Anti‑SARS-CoV-2 Total N Antibody Calibrators (anti-SARS-CoV-2 in buffer with bovine serum albumin and antimicrobial agent
1.0 mL)
CALIBRATOR, VITROS SARS-COV-2 TOTAL N AB (2/PK) D/S
Calibrator Kit Vitros® Anti-SARS-CoV-2 Total N Antibody For VITROS ECi / ECiQ / 3600 Immunodiagnostic Systems and the VITROS 5600 / XT 7600 Integrated Systems Lyophilized
SKU
2001192948
Price
$148.22
Weight
5.00
Featured Product
No
Manufacturer Sku
6199976
UOM
PK
Manufacturer
Vitros®
Short Description
CALIBRATOR, VITROS SARS-COV-2 TOTAL N AB (2/PK) D/S