Respiratory Test Kit OSOM® COVID-19 Antigen 40 Tests
 
Manufacturer #
1066-40
Brand
OSOM®
Manufacturer
Sekisui Diagnostics
Country of Origin
United States
Application
Respiratory Test Kit
Contents 1
(40) Test Devices containing LFI Test Strip in Plastic Housing, 2 X (20) Nasal Swab Specimen Collection and Dispensing Tubes with OSOM Antigen Buffer, IFU, Quick Ref Guide
Is_ECAT
N
Is_GSA
Y
Is_VA
N
Number of Tests
40 Tests
Product Dating
McKesson Acceptable Dating: we will ship >= 60 days
Purchase Program Type
Standard Purchase
Reading Type
Visual Read
Sample Type
Direct Mid-Turbinate Nasal Swab Sample
Specialty
Immunoassay
Test Format
Test Device Format
Test Kit Type
Rapid
Test Method
Lateral Flow Chromatographic Immunoassay
Test Name
Covid-19 Antigen
Time to Results
15 Minute Results
UNSPSC Code
41116144
 
Features
OSOM Covid-19 Antigen Rapid Test is for use under an FDA EUA: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
OSOM® COVID-19 Antigen Rapid Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct midturbinate (MT) nasal swab specimens from individuals who are suspected of COVID-19
Qualitative detection of the SARS-CoV-2 nucleocapsid protein antigen in direct mid-turbinate (MT) nasal swab specimens collected by a healthcare provider from individuals suspected of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests
For 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
Positive results indicate the presence of viral antigens, but clinical correlation with past medical history and other diagnostic information is necessary to determine patient 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 results to the appropriate public health authorities
All 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 measures such as isolating from others and wearing masks
 
MFR# 1066-40
SKU: 314-0130
SKU2: 1232792