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SLI Medical Acceptable Dating: we will ship >= 30 days
Test Name
Visual Read
Test Type
Nasal Swab Sample
Time to Results
USP Controlled Room Temperature
UNSPSC Code
Cassette Format
Lateral Flow Immunochromatographic Assay
Covid-19 Antigen
Antigen Detection
10 Minute Results
41116205
Features
Product ships from McKesson with minimum 30 days dating
Anterior Nares / AN Swabs
This product has been authorized by the FDA under its Emergency Use Authorization
Customers should review requirements
including notification of public health authorities
as they are stated here: https:www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices
Emergency use of this test is limited to authorized 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 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
Positive results indicate the presence of viral antigens
but the clinical correlation with patient history and other diagnostic information is necessary to determine infection status; Positive results do not rule out a bacterial infection or co-infection with other viruses
Negative results are 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
CareStart™ COVID-19 Antigen test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2 in anterior nare (nasal swab) specimens either directly collected or collected in BD universal transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of symptom onset
Identify acute infection with 87.2% sensitivity and 100% specificity
Intended at POC setting (i.e.
in patient care settings) by medical professionals with a CLIA waiver
TEST, COVID-19 CARESTART ANTIGEN RAPID AN SWAB (20TEST/KT)
