Rapid Check COVID-19/ Flu A&B Antigen Test POC

Description

Cost Plus Medical Technologies: Healgen® Rapid Check COVID-19/Flu A&B Antigen Test Kit

Features and Benefits

• Triple Virus Detection: Identify SARS-CoV-2, Influenza A, and Influenza B with a single test.
• Rapid Results: Obtain results in as little as 15 minutes.
• Symptomatic Testing: Ideal for individuals showing signs and symptoms of respiratory infection within the first 5 days of onset.
• User-Friendly: Easy-to-use shallow nasal swab suitable for ages 2 and older.
  • For children aged 2 to 13, swabbing should be conducted by an adult.
  • Individuals aged 14 and up can perform the self-test.
• Clinical Utility: Authorized for use by CLIA certified laboratories, this test provides critical information to help healthcare providers make informed decisions.

Important Information

• EUA Authorization: This test is authorized under the FDA’s Emergency Use Authorization (EUA) for use by authorized laboratories. It has not been FDA cleared or approved.
• In Vitro Diagnostic Use: Exclusively for diagnostic use, not for detecting influenza C antigens or differentiating SARS-CoV and SARS-CoV-2.
• Limited Duration: Authorized only for the duration of the emergency declaration under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, unless terminated or revoked earlier.
• Contextual Results: All negative results are presumptive and should be confirmed with a molecular assay if needed. Positive results require clinical correlation with patient history and additional diagnostic information to determine infection status.

Technical Specifications

• Sample Type: Nasal Swab
• Usage Temperature: Store between 36-86°F (2-30°C)
• Regulations: Suitable for use in laboratories with CLIA certification, under moderate, high, or waived complexity tests; appropriate for Point of Care (POC) settings.

Order Now at Cost Plus Medical Technologies!

Visit costplusmedtech.com to purchase the Healgen® Rapid Check COVID-19/Flu A&B Antigen Test Kit today! Get the reliable, rapid results you need to guide patient care and infection control decisions with confidence.