Description
Contents: 25 test cassettes, 25 Sterile Swabs, 25 Buffer Tubes, 1 Package Insert
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.
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen
Shelf Life: 10/06/2026 Expiration Date
Storage Requirements: 36° – 86° F
Processing Time: Approximately 15 Minutes
Resources:
- EUA-AzureBiotech-FastepAg-ifuHT (1)
- 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.
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