COVID-19/Flu A&B Test Kit (25/bx)

• Accurate Detection & Differentiation Between SARS-CoV-2, Flu A & B
• Reliable Results in Just 15 Minutes
• FDA EUA Authorized for Authorized Laboratories
• Direct Shallow Anterior Nasal Swabs
• Easy Interpretation of Efficient Diagnosis
• Complete Kit for Easy Point-of-Care Testing .

The Healgen Scientific COVID-19/Flu A&B Test Kit is a reliable, and easy-to-use rapid lateral flow immunochromatographic assay that detects and differentiates SARS-CoV-2, Influenza A, and Influenza B. It provides accurate results in as fast of 15 minutes, ensuring proper diagnosis for the healthcare professional at the point of care.

✔ Detects 3 Viruses at Once | ✔FDA EUA Authorized | ✔ 15-Minute Results

SIMPLE & EFFICIENT TEST KIT

EASY SAMPLE COLLECTION: Direct, shallow anterior nasal swab collection is done to a symptomatic patient, within the first 5 days of symptom onset.

QUICK RESULTS: Clear, easy-to-read results can be obtained within 15 minutes. Reading and interpreting of results must be done not later than 20 minutes, to achieve accurate results.

EASY INTERPRETATION: A positive result will show two lines on the control line "C", and a line on either the Covid, FLU A, or FLU B area, while a negative result will only show the lines on the "C", and blank on the others. A result is invalid if one of the two control lines are missing.

COMPLETE MATERIALS INCLUDED: The box contains sealed test cassettes, sterile nasal swabs, pre-filled extraction tubes, tube tips, and tube holders. Reference guide and simple instructions for use sheet are also included on the package.

Offers Controls: Positive and Negative External Controls are "Available Upon Request". You may choose between: 1 Each Negative and Positive Control Swabs (GCFC-PN2) or 10 Each Negative and Positive Control Swabs (GCFC-PN20).

DIRECTIONS FOR USE:

FDA Disclaimers: This product is not FDA cleared or approved, but only authorized under an Emergency Use Authorization (EUA) for use by authorized laboratories. It is authorized for the rapid detection of proteins from SARS-CoV-2, Influenza A & Influenza B and not for any other viruses or pathogens.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the 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.

PRODUCT DOCUMENTATIONS:

• Healgen COVID-19/Flu A&B Combo Instructions for Use (IFU) EUA
  
• Healgen COVID-19/Flu A&B Combo POC Patient Fact Sheet
  
• Healgen COVID-19/Flu A&B Combo POC Healthcare Providers Fact Sheet (HCP)
  
• Healgen COVID-19/Flu A&B Combo Quick Reference Guide
  
• Healgen COVID-19/Flu A&B Combo Control Kit Instructions for Use (IFU) EUA

WARNING: This product can expose you to chemicals known to the State of California to cause cancer. For more information, go to www.P65Warnings.ca.gov.