This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC) by qualified healthcare professionals, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- Lateral flow assay
- Rapid results in 10 minutes
- Minimally invasive specimen collection (nasopharyngeal)
- Intended at POC setting (i.e., in patient care settings) by medical professionals
- Made in the U.S.A
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Identify acute infection with high sensitivity and 100% specificity
PLEASE NOTE: Information above in this section might be an overall summary about the product line and not in regards to the specific product. If you have any questions, Please E-mail or Call 1-855-360-5460.