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 with Sofia 2 Fluorescent Immunoassay Analyzer
25 Tests
SLI Medical Acceptable Dating: we will ship >= 30 days
Machine Read
Nasal Swab Sample
Cassette Format
Flu + SARS Antigen FIA
Fluorescence Immunoassay (FIA)
15 Minute Results
41116144
Features
For use on Sofia 2 analyzers ONLY - test cannot be run on a Sofia 1 analyzer; reach out to your account manager with any analyzer questions or requests
Product ships with minimum 30 days dating
Sofia 2 Flu + SARS Antigen FIA is for use under an FDA EUA: https:www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
Emergency use of this test 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 high
moderate or waived complexity tests
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act
21 U.S.C. § 360bbb-3(b)(1)
unless the authorization is terminated or revoked sooner
The Sofia 2 Flu + SARS FIA is intended to be used with direct nasal or nasopharyngeal swabs and is not validated for use with viral transport media
The test is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2
influenza A virus
and influenza B virus nucleocapsid protein antigen
but does not differentiate
between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens
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 SARS-CoV-2results to the appropriate public health authorities
Negative results do not rule out COVID-19 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
Negative SARS-CoV-2 results
from patients with symptom onset beyond five days
should be treated as presumptive and confirmation with a molecular assay
if necessary
for patient management
may be performed
The Sofia 2 Flu + SARS Antigen FIA is intended for use on the Sofia 2 only and by medical professionals or trained operators who are proficient in performing tests using the Sofia 2 Instrument; the Sofia 2 Flu + SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization
Accurate detection with direct samples
Results in 15 minutes
12-month shelf life from date of manufacture
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act
21 U.S.C. § 360bbb-3(b)(1)
unless the authorization is terminated or revoked sooner
Room temperature storage
TEST KIT, SOFIA FLU & SARS ANTIGEN FIA ASSY (25/KT 12KT/CS)