(Box) COVID-19/Flu A&B Combo Rapid Test - CLIA Waived, 25 Tests

Detect and differentiate COVID-19, Influenza A, and Influenza B in a single rapid test. The Healgen® Rapid Check® COVID-19/Flu A&B Antigen Test Pro is a CLIA-waived lateral flow immunochromatographic assay for professional point-of-care testing using anterior nasal swab specimens.

Current Product Information

• Manufacturer: Healgen
• Manufacturer Catalog / REF: GCFC-525SKa-25T
• Kit Size: 25 tests per box
• Specimen Type: Anterior nasal swab
• Detected Analytes: SARS-CoV-2, Influenza A, and Influenza B antigens
• CLIA Complexity: Waived
• FDA Regulatory Reference: DEN240029
• Storage: 36–86°F (2–30°C)
• Stability: 24 months

What Does This Test Detect?

This combination rapid antigen test is designed for the qualitative detection and differentiation of:

• SARS-CoV-2 nucleocapsid antigen (COVID-19)
• Influenza A nucleoprotein antigen
• Influenza B nucleoprotein antigen

Because COVID-19 and influenza can produce similar respiratory symptoms, a combination test can help healthcare professionals distinguish among these respiratory infections using one anterior nasal swab specimen.

Professional Point-of-Care Use

The Healgen Rapid Check COVID-19/Flu A&B Antigen Test Pro is intended for use with individuals experiencing signs and symptoms of respiratory tract infection. Adults may administer the test to children ages 2 years and older, and individuals ages 14 years and older may self-collect their anterior nasal swab specimen as permitted by the product instructions for use.

Key Features

• Tests for COVID-19, Influenza A, and Influenza B from one specimen
• Anterior nasal swab collection
• Visual lateral-flow format with no laboratory analyzer required
• CLIA waived for eligible point-of-care settings
• 25 tests per box
• Suitable for clinics, physician offices, urgent care centers, and other healthcare facilities

Regulatory Information

This listing is for the current Healgen professional product, manufacturer catalog number GCFC-525SKa-25T. The product is associated with FDA De Novo authorization DEN240029, and the Healgen Rapid Check Flu A&B/COVID-19 Antigen Test Pro is listed by FDA as CLIA Waived.

This is not the discontinued GCFC-525Sa EUA-only product.

Bulk & Healthcare Facility Pricing

Big Ben Medical Supplies serves physician offices, urgent care centers, multi-location healthcare organizations, and hospital systems. Volume pricing and custom quotes are available for larger quantities and recurring supply needs.

• Volume pricing for healthcare facilities
• Multi-location pricing support
• Custom quotes for larger orders
• Michigan-based inventory for fast fulfillment when stock is available

Official Product References

• Healgen Rapid Check COVID-19/Flu A&B Antigen Test Pro
• FDA De Novo DEN240029