Description
EUA-AzureBiotech-FastepAg-ifuHT (1)
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories.
Contents: 25 test cassettes, 25 Sterile Swabs, 25 Buffer Tubes, 1 Package Insert
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
Storage Requirements: 36° – 86° F
Processing Time: Approximately 15 Minutes
CPT Code: 87811QW
The Fastep COVID-19 Antigen Home Test is lateral flow immunoassay intended for the qualitative detection of
nucleocapsid 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 or adult collected anterior nasal (nares) swab samples from individuals aged two
years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 5 days of symptom
onset when tested twice over three days with at least 48 hours between tests, and for 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
The Clarity COVID-19 Antigen test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity, moderate complexity, or waived tests. This test is authorized for use at the Point of Care (POC), i.e., patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Our CLIA Waiver can be found on the FDA’s website at the following link: https://www.fda.gov/media/149056/download
See product links above for additional information or contact your local Stat Technologies sales representative
