Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved Contents: (20) Sealed Test Devices, (20) Assay Buffer, (20) Extraction Vials and Caps, (20) Specimen Collection Swabs, (1) Positive and (1) Negative Control Swabs , (1) Instructions for Use Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen Storage Requirements: 34° – 86° F Processing Time: Approximately 10 Minutes
Intended to be a point-of-care (POC) test, the CareStart COVID-19 Antigen Rapid Test has a 10 minute processing time and allows effective screening of COVID-19 infection on a large scale without the use of a separate analyzer.
Minimally invasive specimen collection (anterior nasal or nasopharyngeal) Lateral flow assay Rapid results in 10 minutes (do not read after 15 minutes) Intended for point-of-care settings by medical professionals CLIA waived For in vitro diagnostic use only Prescription use only This will detect the current European mutations as well!
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