COVID 19/Flu A&B Rapid Test EUA Authorized

Description

COVID 19 Flu A&B Rapid Test

The Healgen® COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

Authorized by the FDA under an Emergency Use Authorization. Testing is limited to 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 test 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.

• Test kits should be used immediately after opening
• Do not use an expired test kit

EUA Statement

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.

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.

Standard Product

Each box of COVID-19 Flu A/B Antigen Tests include:

• 25, individually sealed test cassettes
• 25, sterile nasal swabs
• 25, pre-filled extraction tubes
• 25, extraction tube tips
• 2, tube holders
• 1, instructions for use insert
• 1, healthcare provider fact sheet
• 1, patient fact sheet
• 1, quick reference guide

Product Documentation & Fact Sheets

The following documentation contains vital product information, use instructions, materials needed and clinical performance data.

Product Insert

Healthcare Provider Fact Sheet

Patient Fact Sheet

Product Guide/Use Instructions

Controls IFU