Respiratory Covid-19 + Flu A&B Combo test Kit - Box of 25 ($9.96 each)

Healgen COVID-19/Flu A&B Ag (25 Tests per Box) - Priced per Box

Combo Rapid Test Cassette (Swab)

Rapid • Reliable • Simple

The Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow assay for detecting and differentiating influenza A, influenza B, and SARS-CoV-2 antigens from anterior nasal swabs of individuals with COVID-19 symptoms.
The test is for Point-Of-Care professional use only.

• Detect Three Respiratory Viruses Simultaneously from a Single Sample
• Rapid Detection
• Excellent Test Performance
• Simple and Effective
• Suitable for 2+ years old
• External Quality Controls Available
• Shelf Life that Spans Viral Seasonality

Important Notes

The Healgen® COVID-19/Flu A&B Ag Combo Rapid test Cassette (Swab) has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories.

This product has been authorized only for the detection of proteins from SARS-CoV-2, influenza A and influenza B, not for any other viruses or pathogens.

The emergency use of 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. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Authorized Laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high, or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.