Siemens 11561909 - Respiratory Test Kit… | USA MedPremium
Respiratory Test Kit Clinitest® At-Home OTC COVID-19 Test 800 Tests CLIA Waived
USAMP#56260312SKU: 11561909Clinitest®
Product Spotlight
The CLINITEST® Rapid COVID-19 Antigen Self-Test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
The CLINITEST® At-Home OTC COVID-19 Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2
This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection
Positive results indicate the presence of viral antigens, but clinical correlation with past medical 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
Individuals who test positive with CLINITEST® Rapid COVID-19 Antigen Self-Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
Negative results 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
Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
With the CLINITEST® Rapid COVID-19 Antigen Self-Test, you can expect accurate and reliable results in just 15 minutes
