Flowflex COVID-19 Antigen Home Test

Reference Number: L031-118B5

Product Description

The Flowflex COVID-19 Antigen Home Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older.

Features:

• Easy-to-use nasal swab test
• Can be used to test children as young as 2 years old
• For use with and without COVID-19 symptoms
• Accurate results in 15 minutes
• Compact packaging for “On-The-Go” testing

Clinical Performance: Anterior Nasal

Product Documentation

• Instructions for Use (Home Use)
• Instructions for Use
• Fact Sheet for Healthcare Professionals
• FDA EUA Letter

Safety Information

• For in vitro diagnostic use only.

Disclaimers

• This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA;
• This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and,
• This product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

For information on the EUA, IFU, and purchase orders please contact your local sales representative or contact us at orders@lochnessmedical.com or 1-888-506-2658.

Product Information

• Product Code: Flowflex COVID-19 Antigen Home Test
• Sample: Self-collected anterior nasal (nares) swab specimens
• Format: Cassette
• Time-to-Result: 15 minutes
• Storage Condition: 36-86°F/2-30°C
• Test Principle: Lateral Flow Chromatographic Immunoassay

Contents

• 1 Test Cassette
• 1 Extraction Buffer Tube
• 1 Disposable Nasal Swab
• Package Insert