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For use in Conjunction with the LumiraDx SARS-CoV-2 Ag Test Strip System on the LumiraDx Instrument
Form
Liquid
Levels
Positive Level / Negative Level
Product Dating
SLI Medical Acceptable Dating: we will ship >= 30 days
Storage Requirements
Requires Refrigeration
Test Name
SARS-CoV-2 Ag
Test Type
Antigen Test
UNSPSC Code
41116128
Volume
4 X 0.5 mL
Features
The LumiraDx SARS-CoV-2 Ag Test is for use under an Emergency Use Authorization 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 263a
that meet the requirements to perform moderate
high or waived complexity tests
This test is authorized for use at the Point of Care (POC)
i.e.
in patient care settings operating under a CLIA Certificate of Waiver
Certificate of Compliance
or Certificate of Accreditation
The LumiraDx SARS-CoV-2 Ag test does not differentiate between SARS-CoV and SARS-CoV-2
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
Negative results
from patients with symptoms onset beyond twelve days
should be treated as presumptive and confirmation with a molecular assay
if necessary
for patient management
may be performed
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
The LumiraDx SARS-CoV-2 Ag Quality Controls (hereafter referred to as Quality Controls) are liquid quality controls to be used with the LumiraDx Instrument (hereafter referred to as the Instrument) and the LumiraDx SARS-CoV-2 Ag Test (hereafter referred to as SARS-CoV-2 Ag Test)
The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip
The LumiraDx SARS-CoV-2 Ag Test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings
and proficient in performing tests using the LumiraDx Instrument This test is o
Kit contents: 2 X 0.5ml vial SARS-CoV-2 Ag Positive Control
2 X 0.5ml vial SARS-CoV-2 Ag Negative Control
24 Transfer pipettes (20µl)
LumiraDx SARS-CoV-2 Ag Quality Control Pack Insert
Requires: LumiraDx Instrument
LumiraDx SARS-CoV-2 Ag Test Strips
and LumiraDx Connect– if connectivity required (refer to LumiraDx Connect User Manual)
