Subscribe to the SLI Medical mailing list to receive updates on new arrivals, special offers and our promotions.
The store will not work correctly in the case when cookies are disabled.
Get Up to 25% OFF PPE MasksGowns * Limited time only.
SLI MEDICAL IS A WHOLESALE SITE! WE ONLY SELL TO QUALIFIED FACILITIES (Such As Hospitals, Physician Offices, & Distributors). All Addresses are Verified.
For use in Calibration of Access SARS-CoV-2 IgM Assay on Access Family of Immunoassay Systems only
Form
Liquid
Levels
Level 1
Product Dating
2
Storage Requirements
SLI Medical Acceptable Dating: we will ship >= 30 days
Test Name
Requires Refrigeration
Test Type
SARS-CoV-2 IgM
UNSPSC Code
Antibody Test
Volume
41116145
2 X 2 mL
Features
The Access SARS-CoV-2 IgM Assay is only for use under the FDA's Emergency Use Authorization: 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 requirements to perform moderate or high complexity tests
Access SARS%XE2%X80?CoV%XE2%X80?2 IgM is a paramagnetic particle
chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to SARS%XE2%X80?CoV%XE2%X80?2 in human serum
serum separator tubes and plasma (lithium heparin
dipotassium EDTA
tripotassium EDTA
sodium citrate)
Access SARS%XE2%X80?CoV%XE2%X80?2 IgM is intended for use as an aid in identifying individuals with an adaptive immune response to SARS%XE2%X80?CoV%XE2%X80?2
indicating recent or prior infection; at this time
it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.
Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
The sensitivity of the Access SARS-CoV-2 IgM assay early after infection is unknown; negative results do not preclude acute SARS-CoV-2 infection
False positive results for the Access SARS%XE2%X80?CoV%XE2%X80?2 IgM assay may occur due to cross%XE2%X80?reactivity from pre%XE2%X80?existing antibodies or other possible causes; due to the risk of false positive results
confirmation of positive results should be considered using a second different assay
The Access SARS-CoV-2 IgM Calibrators are intended to calibrate the Access SARS-CoV-2 IgM assay for the in vitro qualitative detection of SARS-CoV-2 IgM antibodies in human serum
serum separator tubes and plasma (lithium heparin
dipotassium EDTA
tripotassium EDTA
sodium citrate) for use on the Access Family of Immunoassay Systemsonly
The Access SARS-CoV-2 IgM Calibrators are provided as: negative and positive; assay calibration data are valid up to 28 days
Provided ready to use
