CareStart Antigen COVID 19 Test - Ag Rapid CLIA Waived Point of Care SARS-CoV-2
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CareStart Antigen COVID 19 Test - Ag Rapid CLIA WAIVED POINT OF CARE for SARS-CoV-2
Results: 10 Minutes
Technology: Lateral Flow Assay
Target: Point of Care Testing by Medical Professionals
Quantity: 20 tests per box
Due to the highly contagious nature and global health crisis, SARS-CoV-2 has been designated as a pandemic by the World Health Organization (WHO) and continues to have devastating impacts on healthcare systems and the world economy including the U.S. To effectively end the SARS-CoV-2 pandemic, systematic screening and detection of both clinical and asymptomatic COVID-19 cases is critical.
As an intended point-of-care (POC) designated test with a 10 minute processing time, CareStart™ COVID-19 Antigen Test allows effective screening of COVID-19 infection on a large scale.
Letter of Authorization: https://www.fda.gov/media/142916/download
Fact Sheet for Healthcare Providers: https://www.fda.gov/media/142917/download
Fact Sheet for Patients: https://www.fda.gov/media/142918/download
Instructions for Use: https://www.fda.gov/media/142919/download
The CareStart™ COVID-19 Antigen test Letter of Authorization, along with the authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Patients, and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas.
PROFESSIONAL USE ONLY:
PROFESSIONAL USE ONLY